Position Summary:

The Quality Assurance Specialist III will provide on-site advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components. In addition, this position is responsible for managing the document and record control system. Extended work hours may be necessary in order to meet business demands.

Essential functions of the job include but are not limited to:

Quality Function:

• Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):

*Non-Conformances

*Customer Complaints

*Planned Deviations

*Change Management

*Corrective and Preventive Action (CAPA)

*Supplier Quality Management

*Audit Programs

*Employee Training

*Document & Record Control

• Participating on the Material Review Board and Safety Committee
• Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities; serve as lead auditor
• Analyze data resulting from monthly metrics and reporting tools for all aspects of quality systems, connecting data and forming conclusions regarding the compliance health of PFM, to include presentation of metric performance to management representatives and proposing durable solutions
• Respond to supplier look-back notifications. Investigate and determine disposition of material
• Support laboratory management with monitoring equipment calibration program to ensure timely and accurate completion of maintenance
• Independently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies
• Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews
• Lead departmental projects aimed operational process understanding efforts (process mapping)
• Act as a change-agent and QA lead during continuous improvement and global harmonization efforts
• Provide guidance to junior level QA specialists
• Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings and customer complaints
• Create and conduct site-wide training for multiple disciplines

Operations Support:

• Serve as quality lead for validation activities, including review and approve validation protocols, reports, and final package documentation
• Assist in the QA review and acceptance of customer specifications to conform to contractual requirements
• Generate and maintain label formats for manufactured and resale products
• Generate and maintain Certificates of Analysis for finished products and products for resale
• Inspect and approve all product labels generated by Operations
• Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested
• Develop and distribute controlled quality system documentation
• Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
• Develop and maintain databases/spreadsheets for document control
• Maintain filing and storage systems for document control, training and batch records for raw and finished product
• Perform area walkthroughs and audits for compliance to written expectations
• Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability

Inspection and release:

• Inspect and release incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating procedures
• Perform batch record review and release for finished product, raw materials, intermediate solutions, and services
• Conduct product inspections, review repack records

Miscellaneous:

• Assist in training new and existing personnel
• Participate in regulatory, notified body, and customer audits as needed
• Provide back-up coverage for other Quality Specialists
• Carry out other duties/projects as assigned
• Clinical quality experience preferred but not required

Qualifications:

Minimum Required:

• Bachelor’s Degree or equivalent combination of education and experience
• 4 years of related experience in a life science, regulated environment

Other Required:

• Experience working in a Quality Department/Life Sciences-Regulated environment, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection
• Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
• Must become an active member of Society for Quality Assurance (SQA). Company will support the membership fees.
• Ability to meet deadlines and perform administrative functions
• Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
• Ability to organize tasks, work independently and adapt to changing priorities
• Ability to function independently within a minimally supervised environment with exceptional attention to detail required
• Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
• Must be able to read, write, speak, fluently and comprehend the English language