JOB SUMMARY

Responsible for driving all aspects of the Analytical and Microbiological Quality Control (QC) laboratories at Genezen. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. This person is also the facility aseptic subject matter expert, including responsibilities for the environmental monitoring program. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab.

ESSENTIAL JOB FUNCTIONS

• Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
• Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
• Monitor, maintain and continuously improve the environmental monitoring program, including conducting Environmental Monitoring Performance Qualifications as needed
• Develop, implement and maintain EM trending program and metrics, including Annual Reports and evaluation of alert levels
• Develop, implement and maintain an in-house isolates program
• Responsible for Disinfectant Efficacy Program
• Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines.
• Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
• Support the tech transfer of bioassays from clients to cGMP QC testing lab
• Represent QC Analytical and Microbiological in client meetings and programs
• Establish and maintain the stability program
• Oversee LIMS development, implementation, operation, troubleshooting and maintenance
• Responsible for all laboratory logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc.
• Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
• Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
• Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of cell and gene products
• Develop, implement and present metrics for monitoring of lab operations and stability program
• Participation in client audits and regulatory inspections as SME and development of responses to observations
• Responsible for hiring and development of team members, conduct performance review and disciplinary actions.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

 KNOWLEDGE, SKILLS, AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

About the Role

As a Channel Sales Manager, National Partners (Midwest) you'll be pivotal in scaling Verkada's reach and impact by developing and managing a network of high-performing LVARs (large value-added resellers). You'll be responsible for driving net new business through the channel—building pipeline and executing strategic plans that result in measurable growth.

This individual contributor role requires strategic thinking and hands-on execution as you collaborate across sales, marketing, and partner teams to grow Verkada’s presence nationally. 

What You’ll Do

In this role, you’ll be at the heart of Verkada’s mission, working hand-in-hand with our sales teams to drive growth and success with channel partners. You’ll be responsible for building pipeline and generating net new business through reseller partners while executing a best-in-class channel strategy. Here’s what you’ll own:

• Drive Net New Pipeline: Proactively identify and generate pipeline with named strategic Large VARs. Collaborate closely with field sales teams to co-sell and close high-value opportunities.
• Execute National Channel Strategy: Develop and manage a focused partner business plan for your territory that aligns with Verkada’s overall GTM objectives and quarterly sales targets.
• Empower Our Partners: Train and enable partner executives, sales teams, and technical stakeholders on Verkada’s full product portfolio, programs, and campaigns to ensure deep engagement and capability across all levels.
• Collaborate Cross-Functionally: Work closely with Verkada’s internal sales, marketing, and pre-sales teams to drive joint activities, including partner events, demand generation campaigns, and customer-facing initiatives.
• Lead with Insight: Conduct regular QBRs and ad-hoc business reviews with partners to align on priorities, track performance, celebrate wins, and identify opportunities for improvement.
• Strengthen the Channel Ecosystem: Influence partner sales teams to prioritize Verkada in key deals and business planning efforts. Leverage insights from the field to recommend improvements to Verkada’s channel tools, incentives, and partner program offerings.
• Drive Awareness and Demand: Lead and participate in regional in-person and virtual events to grow Verkada’s brand awareness, build community, and strengthen relationships with key partner contacts and stakeholders.
• Operate Strategically and Tactically: Own the full lifecycle of partner engagement in your region—from onboarding and enablement to pipeline development and revenue realization.
• This role requires regular travel, estimated to be more than 50% of the time, including both domestic and international destinations as needed. The successful candidate must be comfortable with frequent travel to support business operations, customer and partner engagements and team collaboration. 

What You Bring

• Experience & Success: 5+ years of channel sales or partner management experience with a strong track record of building new business via Security Integrators or IT LVAR partners. Experience managing and growing partners: Sentinel, NTT, World Wide Technologies, AHEAD, or Marco Technologies is highly preferred.
• Recognition, such as President’s Club, is a plus.
• Strategic & Creative Thinking: A process-driven approach, complemented by innovative thinking to create scalable, partner-focused initiatives.
• Relationship-Builder: Ability to influence and engage across all levels—from partner sales reps to executive leadership.
• Technical Fluency: Comfortable navigating product discussions and sales operations. Proficiency in Salesforce, Excel, and business intelligence tools.
• Clear Communicator: Strong verbal and written communication skills with sharp attention to detail and a professional presence.
• Midwest based (near a major city/airport): Must be open to 50% travel across the country.

US Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Healthcare programs that can be tailored to meet the personal health and financial well-being needs - Premiums are 100% covered for the employee under at least one plan and 80% for family premiums under all plans
• Nationwide medical, vision and dental coverage
• Health Saving Account (HSA) with annual employer contributions and Flexible Spending Account (FSA) with tax saving options
• Expanded mental health support
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, flexible PTO and personal sick time
• Professional development stipend
• Fertility Stipend 
• Wellness/fitness benefits
• Healthy lunches provided daily
• Commuter benefits

Additional Information

• You must be independently authorized to work in the U.S. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time.

Verkada is building a world-class sales organization. Our business requires highly motivated and capable sales professionals. We prioritize drive and demonstrated success in whatever sales role you’ve been in before — we care far less about fancy pedigrees, schools, or a resume with “brand name” companies. We have a fun, positive culture of success, and of course, we pay well.

What You'll Do

• Source and close new business to consistently meet or exceed quarterly sales quotas
• Build an intimate understanding of Verkada products and their place in the industry
• Manage the full sales cycle: Prospect for new customers, host online demos, create proposals, and close deals
• Maintain accurate pipeline management with expert-level forecasting 
• Aggressively exceed goals consisting of outbound phone calls, emails, online demos, and trials every quarter
• Act as a trusted advisor and subject matter expert to customers and channel partners
• Work closely with Customer Success to ensure smooth launches and fuel future product growth
• Provide market/client feedback to Verkada’s product/engineering team

What You Bring

• 5-10+ years of quota exceeding Sales experience working for a technology vendor selling Enterprise solutions into State Agencies
• Prior Experience in Government procurement processes and regulations, security standards and policies
• Experience responding to Government RFI's and RFP's
• A track record of developing a greenfield territory, adding net new logos in an Enterprise software role
• Hunter mentality with solid Sales DNA
• Strong verbal and written communications skills
• BS/BA degree strongly preferred

US Employee Benefits

Position Overview

Woolpert is hiring a Site Civil Engineer (PE) to join our dynamic Land Development Engineering team. This position reports to the Engineering Team Leader and is responsible for plan production, performing and reviewing design calculations, and assisting project teams with a variety of site/civil land development engineering projects. The Site Civil Engineer will work alongside teams to deliver flawlessly executed designs of site layouts, utilities, sanitary and storm sewer, grading and earthwork, erosion control, stormwater management systems and stormwater pollution prevention plans. 

We are unable to provide visa sponsorship for this position.  Applicants must already possess work authorization in the country the job is located.         #LI-SN1

What You Will Do:

• Design and create site layout plans in alignment with client requirements and Woolpert standards.
• Utilize AutoCAD Civil 3D to develop concept plans, grading plans, and site designs.
• Provide technical support in site/civil design, hydrology/hydraulics, erosion and sedimentation control, and stormwater management
• Coordinate permitting with County and local municipalities.  Experience with local municipalities is a plus.
• Multi-task, appropriately prioritize workflow and complete tasks.
• Work with project management team to identify impediments and develop / implement solutions to overcome obstacles.
• Perform pavement assessments and compiling data and reports
• Occasional field work, frequent local travel, and overnight travel as needed
• Other duties as assigned

What You Will Bring:

• Must have a Bachelor’s Degree in Civil Engineering or related field
• Minimum of 7 years related experience
• Professional Engineer (PE) license required
• Experience in Autodesk Civil 3D
• Demonstrated knowledge of AutoCAD, Civil 3D, Autodesk Vehicle Tracking and Storm and Sanitary Analysis software packages, PondPack, and Microsoft Suite products
• Experience in Hydraulics and Hydrology preferred.
• Must be able to respond effectively to sensitive inquiries from clients, regulatory agencies, and/or members of the business community.
• Demonstrated ability to organize and manage multiple tasks
• Ability to provide excellent client service
• Excellent written and verbal communication skills in a dynamic environment
• Strong organizational, time management, attention to detail and analytical skills
• Ability to work independently as well as in a team environment; offer constructive feedback and direction to support goals

Benefits You Will Love

Certified as a Great Place to Work, Woolpert is one of the fastest-growing architecture, engineering, and geospatial companies in the world. With over 75 offices and countless projects around the globe, you’ll work on meaningful assignments that improve quality of life around the world. In addition to offering competitive pay, we provide employees with a robust set of unique benefits, including:

• Freedom to Work program: Set your own schedule and location (as appropriate).
• Principal program: Earn the opportunity to become an owner of the firm.
• Flexible paid time off/vacation: Take time off when it makes sense for you and your team.
• Career development: Explore a wide range of learning and growth opportunities within and across industries.
• Health, life, vision, and dental insurance: Cover all your medical bases.
• Paid sick time, retirement plan, fitness reimbursement, pet insurance, identity protection, technology stipend, employee assistance program, and more!

OVERVIEW

The Operations Associate is critical in the store team and is responsible for driving profitability and efficiency. The Operations Associate will work closely with the Operations & Visual Management team in initiating, completing work, and providing feedback to the team to achieve optimal results supporting total store operations.  

Key Job Responsibilities 

• Execute inventory management processes effectively with a focus on maximizing inventory accuracy and reducing shrink
• Investigate and root cause inventory accuracy issues, partnering with the General/Store Manager to escalate process or system gaps
• Support execution of key operational functions including shipment, receiving and processing, reverse transfers, sales floor recovery, intra-day sales floor replenishment, floor set updates, and supply management
• Maintain and champion strong visual standards for the sales floor
• Work closely with reporting, budgets, expenses, inventory control, supplies, vendor relationships, technology, and facilities to ensure maintained and maximized
• Support a safe work environment and efficient operation through strong stockroom standards and processes
• Move dynamically on the retail floor to assess and fulfill the needs of the business, team and guests
• Execute company-level operations-focused directives, projects and initiates, in partnership with the Operations & Visual Management team.  
• Assists in processing shipment and ensuring product flow; including but not limited to visual merchandising placement and daily replenishment excellence
• Demonstrate strong business acumen by leveraging metrics to support business-driving strategies
• Resolve client needs quickly & effectively ensuring customer satisfaction
• Identify product concerns and communicate inventory needs to support the business goals
• Duties require constant movement in and around the store, including the sales floor and back of house. When not actively assisting guests, this position takes initiative to perform other tasks, as needed, to keep store clean, safe, inviting and operating efficiently. 

Operations Associate Qualifications 

• 1+ years prior work experience in a client-centric, sales & operational environment
• Requires constant movement in and around all areas of store
• Ability to lift, push, carry or otherwise move up to 50 pounds
• Ability to lift, bend, kneel, climb, crawl and/or twist, and safely climb up/down a ladder
• Ability to stand and move for an entire shift
• Passion for customer service and delivering exceptional experiences
• Self-motivated with a desire to achieve results and excel individually, and as a team
• Aligns with and embodies Alo’s Guiding Principles  

 Operations Associate Schedule 

Part-Time non-exempt associates are expected to work up to 30 hours per week, based on the needs of the business, for a shift minimum of 4 hours. Full-Time non-exempt associates are expected to have open availability, 7 days a week, between 32 - 40 hours. All employees without exception are expected to be able to work during the company’s Blackout period, from the week of American Thanksgiving (including Black Friday and Thanksgiving weekend) through the end of the holiday season (the 1st week of January). 

As an Equal Opportunity Employer, ALO does not discriminate against applicants or employees because of race, color, creed, religion, sex, national origin, veteran status, disability, age, citizenship, marital or domestic/civil partnership status, sexual orientation, gender identity or expression or because of any other status or condition protected by applicable federal, state, or local law. 

JUST SOME OF THE PERKS 

• Generous employee discount for Bella+Canvas, ALO, and free membership to ALO Wellness, with access to hundreds of streaming fitness and yoga classes with top instructors
• Monthly Store Incentives
• Clothing Allowance
• Free yoga classes at any of our Sanctuaries

#LI-JJ1

#LI-2

#li-onsite

The Registered Nurse is responsible for delivering excellent patient care first and foremost, coordinating and ensuring a safe and compliant working environment, assisting in surgical procedures, ensuring accurate and complete patient charting, conducting pre- and post-operative visits, and fostering a spirit of teamwork. 

 
Qualifications: 

• A.D.N. or B.S.N. required; active Compact Nursing License accepted in lieu of state-specific licensure. 

• Maintains active license and meets renewal requirements. 

• Current ACLS certification 

• Proficient in MS Office and EMR systems 

 
Key Responsibilities:  
Patient Care & Clinical Duties: 

• Conduct pre/post-op assessments, patient education, and wound evaluations 

• Support physicians during procedures; monitor patient vitals and safety 

• Administer and document medications; monitor lidocaine use and antibiotic prophylaxis 

• Preference to have Post Op and/or OR Circulator experience.  Not required, will train on job.   

 
Safety, Compliance & Infection Control: 

• Leads emergency drills, maintains Banyan Stat Kit and AED checks 

• Enforces HIPAA, PHI protections, and proper documentation 

• Conducts narcotic counts and monitors medication security 

 
Quality & Records Management: 

• Maintains accurate and timely patient records in compliance with AAAHC 

• Participates in QA/QI initiatives and peer reviews 

• Ensures timely documentation, incident reporting, and follow-ups 

 
Leadership & Communication: 

• Assists with RN/LPN interviews and staff evaluations 

• Educates staff on safety protocols and clinical procedures 

• Collaborates with Practice Manager to ensure adequate medical staffing 

 
Operational Support: 

• Maintains sterile field and proper OR setup 

• Oversees equipment sterilization, stock levels, and clinic readiness 

• Completes daily/weekly logs and inspections per protocol 

 
Physical Requirements: 

• Able to lift 25 lbs., stand/walk for extended periods 

• Visual/hearing acuity and stress tolerance required 

Note: This job description outlines the primary duties and responsibilities of the role but is not intended to be all-inclusive. Additional tasks may be assigned, and existing responsibilities may be modified or removed as necessary to meet operational needs, within the scope of the individual’s role, licensure, and applicable regulatory standards. 

#LI-AH1

Company Overview 

Asset Living is a third-party management firm and a proven partner in fostering thriving communities nationwide. Founded in 1986, Asset Living has decades of experience delivering exceptional value to our partners. Since the beginning, our undeniable passion has driven our organic growth from a small property management firm to one of the most trusted allies in real estate. Asset Living's growing portfolio includes a multitude of properties across the country that span the multifamily, single-family home rentals, affordable housing, build-to-rent, active adult, and student housing divisions.   

Asset Living is a fast-growing company made up of talented individuals from diverse backgrounds that differentiate us and help us drive innovation and results for our clients and communities across the US. At Asset Living, we wholeheartedly believe 'Together We Lead, Together We Succeed. We empower each other to lead by example, collaborate, and evolve – inspired by our belief that we can continually improve as individuals and as an organization. Together, we create an environment where every voice is heard, every idea is valued, and every individual experiences opportunities to grow as our company grows. When you join Asset Living, you become part of a dynamic team that thrives on unity, unique talents, and a universal culture of winning.    

Recognized as one of the nation's Best and Brightest Places to Work and ranked in the NMHC top 50 professionals, join Asset Living because of its reputation as the most trusted partner in real estate, workplace culture, and growth opportunities. Asset Living is a member of The Institute of Real Estate Management (IREM) and is recognized as an Accredited Management Organization (AMO). Together, we lead the way, and together, we achieve excellence in all that we do. Join a workplace where success is a collective journey and leadership is a shared responsibility.   

Regional Manager

The Regional Manager is responsible for overseeing the entire operations of a housing community portfolio. As a Regional Manager, you will manage all phases of the operations, including personnel, leasing, maintenance, financial, administration & risk management. As an offsite leader, you will supervise all aspects of the property and staff to ensure compliance with Asset’s company policies and procedures, safety and fair housing guidelines, and liability concerns.

Essential Duties & Responsibilities

Personnel Management

• Use consistent techniques & company directives to screen, hire, train, coach, and develop on-site staff
• Ensure effectiveness of staff through ongoing training, coaching, counseling, and guidance in compliance with Asset training benchmarks
• Deal effectively and consistently with performance problems; document adequately, communicate with direct supervisor and HR and terminate appropriately when necessary
• Prepare request for a salary increase for Community Manager and assist with other team members if necessary; sign off on all requests from the site
• Ensure all counseling statements, written evaluations, and salary requests are provided for review to the Regional & Senior Vice President and delivered to the Human Resource department
• Approve all timesheets and ensure hours indicated are correct, vacation and sick time reported, and signatures available
• Deal effectively and consistently with performance problems; document adequately, communicate with Regional & Senior Vice President and HR and terminate appropriately when necessary
• Promote harmony and quality job performance of staff through support and effective leadership
• Ensure staff compliance and consistency with Company policies and procedures

Financial Management

• Achieve the highest possible net operating income through the implementation of effective cost control and revenue & leasing improvement; identify trends and recommend strategies and adjustments
• Develop yearly operating budgets/forecasts
• Provide monthly written evaluation of income and expense line items that are significantly over budget
• Provide Capital improvement suggestions for the future of the site
• Monitor all proposals and contracts for large projects at sites and check work in progress
• Monitor & maintain the timely receipt and reconciliation of deposits, rent collections, and charges to ensure submitted on a timely basis
• Monitor & approve the timely receipt, reconciliation, and coding of all vendor invoices
• Ensure property closeout is completed on time and ownership financial reports are accurate

Strategic Leasing Management

• Develop yearly marketing plan and utilize marketing strategies & systems
• Provide marketing strategy to generate rentals or for rent increases
• Ensure staff leasing techniques are effective in obtaining closure, follow up procedures met, signing/documentation of leases, and reporting systems are accurate and up to date
• Deal with resident complaints, concerns, and requests to ensure resident satisfaction
• Develop and implement resident retention programs (i.e., resident functions, special promotions, monthly newsletter, etc.) 
• Effectively show, lease, and move in prospective residents

Administrative & Maintenance Management

• Ensure all administrative & leasing reporting is accurate, complete, and submitted on a timely basis
• Assist with the emergency team for the property; ensures proper response and handling of all property emergencies with staff, residents, buildings, etc. within company guidelines to minimize liability
• Manage excellent customer service and monitor service request turnaround and responsiveness of maintenance staff
• Maintain property appearance and ensure repairs are noted and completed on a timely basis (this requires regular property inspections and tours)
• Plan for and utilize property resources, equipment and supplies economically (i.e., obtaining bids/pricing from vendors, suppliers, and contractors, dealing with inadequate service, etc.)
• Give direction to and monitor maintenance, construction, and rehabilitation activities to ensure quality and expediency (i.e., “walk” units to ensure make-ready and work orders are completed)

Travel

• This position entails travel, estimated at 25-50% of work time annually. Travel may be required for property visits, conferences, training sessions, or other business-related activities.

Education & Experience

• High School Diploma or Equivalent; Bachelor’s degree preferred or four years experience in the housing industry; or one to two years related experience and/or training; or equivalent combination of education and experience 
• Certified Apartment Manager (CAM) or Accredited Resident Manager (ARM) preferred 
• Ability to understand and perform all on-site software functions; basic computer skills required 
• Must have basic knowledge of Fair Housing Laws and OSHA requirements 

This job description should not be considered all-inclusive. It is merely a guide of expected duties. The employee understands that the job description is neither complete nor permanent and may be modified at any time. At the request of their supervisor, an employee may be asked to perform additional duties or take on additional responsibilities without notice. This is a safety-sensitive position and may be subject to additional compliance requirements.

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
• Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
• Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)

Deviation Management

• Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
• Ensure deviations are thoroughly documented, investigated, and closed within required timelines
• Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations

CQV & Compliance Support

• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support validation impact assessments and execution activities related to changes
• Review and approve validation and technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams 
• Support continuous improvement initiatives related to quality systems and CQV processes
• Communicate project status, risks, and issues to stakeholders

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry
• Strong experience with:
  • Change control systems
  • Deviation investigations and root cause analysis
  • cGMP and GDP environments
• Familiarity with device assembly/packaging operations is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities
• Onsite job requirement in Indianapolis, IN

Job Introduction: We are seeking an experienced Senior Program Manager to lead the delivery and implementation of critical manufacturing and quality systems, including MES, CSV, and EMS, within a fast-paced, high-visibility pharmaceutical manufacturing environment. The ideal candidate is a hands-on leader who can drive execution across cross-functional teams, proactively manage risk and ambiguity, and ensure projects are delivered on time, with quality, compliance, and strong stakeholder alignment.

Senior Program Manager Responsibilities:

• Lead end-to-end project delivery across MES, CSV, and EMS initiatives
• Manage project scope, schedule, budget, risks, and dependencies
• Drive coordination between IT, Quality, Manufacturing, and external vendors
• Ensure all systems and processes align with GxP and regulatory expectations
• Oversee validation activities, including planning, execution, and documentation
• Facilitate issue resolution and decision-making across stakeholders
• Provide clear and consistent status reporting to leadership
• Support integration efforts across manufacturing and enterprise systems
• Maintain strong governance and change control throughout the project lifecycle

Job Requirements:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical), Project Management, or related technical field
• 7–12+ years of project management experience in life sciences or regulated industries
• Proven experience delivering MES implementations (e.g., PAS-X, Syncade, Opcenter, etc.)
• Strong background in CSV and validation methodologies (CSA preferred)
• Experience with EMS platforms and integration into manufacturing environments
• Experience with SAP and other Enterprise platforms
• Demonstrated ability to operate in fast-paced, high-pressure environments
• Strong stakeholder management and communication skills
• Experience managing vendors and system integrators
• Familiarity with GxP, 21 CFR Part 11, and data integrity requirements
• Experience supporting greenfield or startup manufacturing environments preferred
• Exposure to biologics, cell and gene therapy, or similar advanced modalities preferred
• PMP or equivalent certification preferred
  

**We are only hiring for this role in the CST or EST time zones**

At Greenlight Guru, we help the world’s most innovative medical device companies bring high-quality, life-changing products to market faster. We serve 1000+ global customers with our quality management and clinical data capture software, helping them get their products on the market and keep them there. 

When you join the team at Greenlight Guru, you’ll be a part of a collaborative, mission-driven team working in one of the most exciting and rewarding industries on the planet. Backed by JMI Equity, one of the premier growth equity firms for SaaS companies, Greenlight Guru is growing—and looking for individuals who are difference makers. Is that you?

We are looking for a commercially-minded, revenue-driven, highly technical Solutions Engineer to join our organization with a heavy focus on selling to software engineering teams. Reporting to the Director of Product Marketing, you are responsible for translating our product strategy into confident, effective value-based selling. You will work alongside Sales to support live deals, bring product and technical depth into buyer conversations, and turn field experience into reusable assets that scale across GTM. You focus on the last mile of the buying journey - proving technical fit, reducing risk, and helping buyers move forward with confidence. While you are a strategic partner to Sales on active deals, being situated within the Product Marketing team allows you to act as a critical bridge between our product’s capabilities and our market-facing message. You are a technical storyteller who knows how to connect "how it works" with "why it matters." You’ll use real-world deal experience to stress-test and refine our positioning, competitive strategy, and the assets we use to win.

Responsibilities

Value Selling & Deal Execution

You own technical confidence in active deals and are accountable for buyer certainty in our technical fit. Your performance is largely measured by your impact on revenue.

• Technical Discovery & Diagnosis: Lead additional deep-dive discovery during demos to uncover a prospect’s current tech stack and pain points. You help diagnose the technical "why" before prescribing a solution.
• Value-Based Demonstrations: Deliver demos tailored to the buyer’s specific goals and success criteria. Lead with value and differentiation, not feature walkthroughs.
• Trial & Evaluation Ownership: Own the trial experience end-to-end, including setup, guidance, and success criteria. Ensure trials clearly demonstrate value and differentiation.
• Technical Deal Support: Act as a persistent partner in the deal, not a one-time resource. Stay current on deal status, identify technical risks, and partner with AEs to move deals forward.
• Expansion & RFP Support: Support expansions and at-risk renewals. Partner with AEs and PMM to ensure RFPs have high positioning impact and technical clarity.

Technical Assets & Demo Environments

You are responsible for maintaining the "technical sales toolkit," ensuring the GTM team has accurate, field-ready assets to sell efficiently.

• Scalable Asset Creation: Build and maintain reusable technical sales assets—such as walkthroughs, video snippets, and PoC templates for APIs/integrations—that help the field scale.
• Demo Environment Ownership: Maintain stable and accessible demo environments. You ensure demo data supports realistic, value-based storytelling for our core personas.
• Demo Narrative: Collaborate with PMM to ensure the core demo narratives are technically accurate and reflect how the product is actually used in the field.

Cross-Functional Collaboration & Enablement

You act as the resident technical authority, ensuring seamless alignment between the Product, Marketing, and Sales organizations.

• Cross-Functional Collaboration: Serve as the trusted technical lead for AEs, AMs, and CSMs. You are a strong collaborator who bridges the gap between technical details and GTM strategy.
• Product Readiness: Stay current on what’s shipping and why it matters. Translate new features into demo-ready flows, technical FAQs, and narratives for the GTM team.
• Field Intelligence Loop: Serve as the "voice of the buyer." Identify patterns in technical objections or competitive gaps and provide clear, actionable feedback to Product to influence the roadmap.

Candidate Profile

• Commercially Minded: You understand that technical depth exists to win deals and drive revenue.
• Strategic Partner: You know when to lead technically and when to support the broader sales strategy.
• Solution Storyteller: You can translate product capabilities into outcomes that actually matter to a buyer.
• Ownership Mindset: You treat deals, proof points, and internal process improvements as your personal responsibility.

Qualifications

• Technical Sales Experience: Proven track record delivering value-led technical demonstrations to software engineers and highly technical buyers, translating complex platform capabilities (APIs, integrations, developer workflows) into clear business and technical outcomes.
• Software Development Fluency: Strong working knowledge of modern SDLC practices, including requirements management, Git-based version control, CI/CD workflows, and release processes, with hands-on experience using Jira and similar developer tools (e.g., issue tracking, sprint boards, workflow configuration) in real engineering environments.
• API & Integration Literacy: Practical understanding of REST APIs, authentication methods, and system integrations - confident discussing how systems connect, how data flows between platforms, and how traceability or automation is maintained.
• Code Familiarity: Hands-on familiarity with code platforms (you have written or actively used code-based tools) and can speak fluently about repositories, commits, pull requests, and automation workflows.
• SaaS Background: Experience at a small-to-mid-sized SaaS company where you helped build or refine the SE function, processes, or demo environments - not just operate within an established structure.
• Revenue Impact: A clear track record of directly supporting revenue, advancing complex opportunities, and influencing deal outcomes in partnership with Account Executives.
• Learning & Ownership Mindset: Thrives in a fast-moving, evolving environment — actively seeks feedback, adapts quickly, rolls with change, and contributes ideas that help the team continuously improve how we sell and deliver technical value.
• Nice to Have: Experience in life sciences/medtech environments or running technical proof-of-concepts.

Benefits you’ll enjoy:

• Flexible Paid Time Off policy and working hours
• Home Office stipend for new hires
• Multiple Medical Insurance options, plus Dental and Vision
• 401k (with company match) 
• Equity Program Eligibility (based on role and/or tenure)
• Paid Maternity and Paternity Leave
• Disability insurance

Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. If you need assistance or accommodations to submit your application for this position, please email careers@greenlight.guru.

About the Job

We’re hiring an Equipment Technician who will focus on critical equipment to ensure that our clinical production team has everything they need to process and bank life-saving bone marrow.  In this role, you’ll be responsible for a variety of facility and equipment cleaning, maintenance, installation, operation, and troubleshooting to keep operations running smoothly in our cGMP (current Good Manufacturing Practice) facility.  This is a hands-on role, and we’ll train you on Good Documentation Practices, preparing tools for sterilization, and other support tasks which are key for a biotech manufacturing facility. Restocking materials and reagents as well as cleaning equipment/tools and autoclaving may also be a part of your daily routine.

This role reports to the Facilities Manager, and will work closely with both the Facilities team and the Clinical Production team.

Required Qualifications

• High School Diploma
• Ability to solve technical and performance problems using information from a variety of sources
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• This is an hourly, non-exempt role based in our Indianapolis facility
• We are currently hiring for Monday through Friday 8am - 5pm

Preferred Qualifications

• Experience working hands-on with laboratory/clinical equipment

Key Responsibilities

• Perform scheduled maintenance inspections and assurance inspections on equipment to ensure safe and effective operating conditions
• Assist with qualification of new equipment
• Test and calibrate components using a variety of manuals, troubleshooting techniques, and code requirements
• Perform routine preventative maintenance and calibrations of equipment
• Assist with cleaning, calibration, and maintenance of quality control, production, and research lab equipment, including non-routine maintenance and scheduling service or calibration with outside vendors as needed
• Assist in repair and replacement of complex medical equipment and systems
• Install and test a variety of medical and research equipment
• Diagnose equipment malfunctions with accuracy
• Perform activities in accordance with current GDP and cGMP 
• Recognize and communicate production and work environment issues/observations to supervisory staff in a timely manner

In your first six months some projects you’ll work on include:

• Training on gowning and cleaning practices for the cleanroom support areas
• Shadowing Clinical Production personnel and observe processing 
• Assisting Clinical Production team in developing improved tool cleaning procedures
• Learning the basics of safety, sterility, and the general flow of our methods and operations
• Understanding our freezers (-80° & -190°) and how they operate, fill and alarm
• Gaining familiarity with switching out Co2 and LN2 tanks

Physical Requirements

• Requires training in blood borne pathogen safety measures; new hires will be given the option of Hepatitis B vaccination
• Requires standing, walking, pushing, kneeling, twisting and reaching
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals 
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time
• Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

We are seeking an experienced and passionate Registered Nurse (RN) with expertise in either the Post Anesthesia Care Unit (PACU), the Operating Room (OR) or both. The ideal candidate will provide high-quality, patient-centered care in an office-based environment with patients under general anesthesia. This role involves supporting surgical procedures in the OR and providing immediate postoperative care in the PACU, ensuring safe recovery, monitoring, and stabilization of patients following anesthesia.  This role will also rotate into office visits for pre and post op appointments.  The candidate must possess critical thinking skills and internal motivation.

Key Responsibilities:

Operating Room (OR):

• Assist in preoperative assessments and preparation of patients for surgery, including premedicating, starting IVs, etc.
• Collaborate with the surgical team, including surgeons, anesthesiologists, and surgical technicians, to ensure smooth and efficient procedures.
• Ensure proper patient positioning, sterility, and safety during surgery.
• Monitor vital signs and patient status throughout the procedure.
• Provide support and assist in the maintenance of a sterile environment and assist in surgical instrument handling.
• Document patient information and surgical data accurately during the procedure.
• Ability and willingness to process instrumentation for surgery.

Post Anesthesia Care Unit (PACU):

• Monitor and assess patients in the immediate postoperative period for any complications or adverse reactions to anesthesia.
• Provide pain management and administer prescribed medications as needed.
• Assess vital signs, level of consciousness, and response to anesthesia, ensuring patient stability and safety.
• Collaborate with the anesthesia team and surgeons to manage and resolve any postoperative issues.
• Educate patients and their families about postoperative care, discharge instructions, and recovery expectations.
• Document patient progress and any complications in the medical record.

Office Based Appointments:

• Accompany surgeon to preoperative visits and assist with preparing and educating the patient regarding upcoming procedures.
• Provide post-operative care including surgical wound checks and assist with post operative medication management.
• Assess vital signs, healing and any other postoperative needs.

General Responsibilities:

• Ensure patient safety by adhering to infection control protocols and hospital policies.
• Demonstrate critical thinking and decision-making in emergency situations.
• Provide compassionate and effective communication with patients, families, and the healthcare team.
• Participate in continuing education and professional development to stay current with medical advancements and nursing best practices.
• Maintain patient confidentiality in accordance with HIPAA regulations.
• Assist in the orientation and training of new nursing staff.

Qualifications:

• Current Registered Nurse (RN) license in the state of practice.
• Minimum of 2 years of experience of either PACU or OR nursing, or both.
• American Heart Association BLS (Basic Life Support) and ACLS (Advanced Cardiac Life Support) certifications required
• Strong knowledge of operative care, anesthesia management, and surgical procedures.
• Ability to work well on a team
• Excellent communication, critical thinking, and interpersonal skills.
• Ability to collaborate effectively within a multidisciplinary healthcare team.

Preferred Qualifications:

• Experience with specific surgical specialties (e.g., plastic, cosmetic, etc.).
• Experience with electronic medical record (EMR) systems.

Work Conditions:

• Full-time or Part-time position, excluding nights, call and company holidays.
• May involve standing for long periods, lifting, and assisting patients as part of routine duties.
• Work in a sterile clinical environment as well as in an office-based setting for office appointments

Physical Requirements:

• Ability to lift up to 25-50 pounds.
• Stand, walk, and move patients as necessary.

#LI-AH1

Job Summary:

We are seeking a Risk Management Project Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 1-3 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint
• Onsite job requirement in Indianapolis, IN

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Senior Automation Engineer Responsibilities:

• Automation Engineer strong in IT/IT-centric systems to help with troubleshooting, detecting issues
• Responsible for design and implementation of key automation aspects of an equipment project, often including PLC, vision, HMI programming.
• General Change management
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Independent verification of testing against specifications
• Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
• Running test scripts and documenting results.
• Adherence with project schedule for all assigned activities.
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team.
• Design and PLC programming (configuration of PLC program) on standard equipment/products
• Lead and perform complex quality checks which require an intricate understanding of the machine control systems and operations
• Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams
• Contribute to the completion of projects, manage own time on agreed targets, develop plans for own projects and leads small project teams
• Monitor, generate and complete the periodic review, validation master plan for the automation engineering program
• Demonstrate good planning, organizing, time management and team participation skills
• Responsible for routine and preventive maintenance work, ensure all the equipment and facilities work safely, efficiently and reliably
• Generate and develop standard operating procedures and system support
• Analyze operational process problems and recommend appropriate corrective and preventative actions
• Manage change control authoring and execution
• Participate in the site and network wide teams to provide cybersecurity alignment and direction
• Provide 24x7x365 support of automation systems and perform automation activities for capital and non-capital projects
• Modify moderately complex to highly complex control logic that requires a degree of scientific and/or manufacturing process expertise
• Clearly communicate progress and issues to peers

Requirements:

• Must have 3-5 years of industrial experience as an Automation Engineer
• Experience in creating SQL databases
• Understanding domain authentication
• Experience in working with IT to schedule implementations
• Able to complete software installs and/or updates
• Creation of databases
• Experience in upgrading system requirements for servers
• Understanding of Citrix application
• GMP and Good Documentation Practice knowledge
• Position requires onsite work in Indianapolis, IN
• Responsible for installing, maintaining, and troubleshooting automated utility, processing, filling, inspection, and packaging equipment
• Generate user requirement specifications for control systems
• Able to make minor modifications to code and HMI graphics for smaller changes
• Must be able to read logic and perform programming as well as update control system documentation
• Contribute technical content to validation protocols on automation systems and perform execution of protocols

Job Summary:

We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 3-5 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

PURPOSE

Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

• Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
• Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
• Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
• Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
• Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
• Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
• Review, assess, and release quality control tests and Certificates of Analysis
• Review and approve executed batch records. Provide guidance and support to departments on errors to ensure error reduction.
• Assist in the final disposition of master cell banks and viral vector products.
• Review and approve qualification/validation protocols and reports and technology transfer reports.
• Provides site GMP and GDP training (annually, for new-hires, and as needed).
• Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
• Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
• Drive Quality Events to closure within on-time closure deadlines.
• Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products,
• Review and approve Master Batch Records.
• Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed.
• Review and approve Stability Protocols.
• Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas
• Initiate, review, approve and monitor Change Management activities
• Work with the other functional areas to give guidance on use of quality systems.
• Assist the Lead Auditors to perform site internal audits.
• Lead and/or support customer audits and regulatory inspections by participating in either front or back room.
• Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Occasionally exposed to loud noise levels
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

Provide maintenance, calibration, and technical support to the manufacturing process and facility equipment.  Coordinate and perform testing and calibration on electrical, mechanical, and analytical equipment for conformance to established standards. Request purchase order requisitions for 3^rd party maintenance requirements.

ESSENTIAL JOB FUNCTIONS

• Assist in creating/establishing a Maintenance and Calibration Program including recommendation of Maintenance and Calibration activities and frequencies based upon system/equipment assessments
• Plan, schedule, and perform planned and unplanned maintenance and calibration on process and facility equipment/utilities including but not limited to HVAC, freezers, cold rooms, bioreactors, filling systems, analytical testing instruments, and building management control systems
• Coordinate and support external calibration service providers
• Build relationships with customers, colleagues, and service partners to provide a collaborative approach to the operational management of lab spaces.
• Track and report on calibration status of all equipment/instruments in the facility
• Ensure timely completion of calibrations/preventive maintenance and compliant record keeping.
• Obtain required documentation and approval prior to creation of purchase order requisition for service requests to be completed by 3^rd party vendors.
• After purchase order has been issued, ensure service delivery dates are correct and revise as necessary, per follow-up with suppliers and customers.
• Source, qualify, negotiate, and procure service contracts in support of lab operations.
• Ensure purchase requisitions are requisitions closed within 180 days and confirm that associated purchase orders are closed as well.
• Enter and maintain records in the Computerized Maintenance Management System (CMMS)
• Meet regularly with key stakeholders (lab staff, service partners, management) to identify, review and resolve issues in a timely manner and/or escalate as necessary.
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

• Associates Degree
• Bachelor's degree 
• EET
• 3-5 years related Calibration/Metrology work experience
• Ability to understand user manuals/specifications, wiring diagrams, equipment Piping & Instrumentation Diagrams (P&ID), and Standard Operating Procedures (SOP)
• Mechanically inclined/knowledge of hand tools
• Proficient with advanced computer systems including the use of a CMMS
• Excellent interpersonal skills and communication skills with ability to act as a change agent

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication 

• Frequently required to communicate by talking, hearing, using telephone and e-mail

About the Job

We’re looking for a Quality Control Associate to provide technical support and execution of tasks within Ossium Health’s Quality Control Laboratory, relating to testing of human bone marrow-derived materials for pre-clinical and clinical use. Successful candidates have a basic understanding of the theory, concepts and regulations behind cGMP regulations and CLIA regulations. You’ll help to ensure that we maintain the highest levels of quality and safety standards on a day to day basis. This is a great opportunity for detail-oriented individuals looking to further a career in biotechnology and quality systems.

Required Qualifications

• BS or BA in biological sciences
• High level of attention to detail in both operations and documentation
• Reliable and able to produce consistent, high quality work
• Great communication skills and organization, able to work as part of a team
• Great work ethic and positive attitude
• Strong computer skills, including Microsoft Office
• Strong attention to detail and observational skills
• This position is based full time in our Indianapolis facility

Preferred Qualifications

• Experience working in a CLIA laboratory, cell therapy, tissue banking, blood banking, or other relevant industry experience
• Experience with flow cytometry, hematopoietic colony forming unit assay, and ELISA
• Exceptional laboratory technique
• Understanding of 21 CFR 210, 21 CFR 211, 21 CFR 1271, 42 CFR 493, AATB Standards, and other GMP requirements
• Strong knowledge of data analysis and statistical methods
• Hands-on experience in MasterControl, including the quality modules and production records

Key Responsibilities

• Perform tests as operator or verifier in the testing of bone marrow derived products 
• Maintain data and documentation related to testing of bone marrow derived products obtained internally or externally
• Update product and sample inventory using an electronic inventory system
• Assist in shipping of testing samples and product from bank
• Perform routine and advanced duties required to clean, maintain and operate testing equipment and storage equipment
• Assist in drafting and revising of departmental procedures
• Work with coworkers and supervisor to effectively troubleshoot equipment and testing issues

Physical Requirements

• Must be able to work aseptically in controlled environments requiring special gowning (i.e. over the head, face, hands, feet and body)
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms.

Schedule

• Full-time (40 hours per week)
• This is an hourly, non-exempt role that is eligible for overtime
• Our QC lab is staffed for testing Monday through Friday, including holidays. The schedule for this position is 4 x 10 hour shifts either Monday-Thursday or Tuesday-Friday

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements