Job Summary

The Quality Assurance Complaints Specialist ensures manufacturing procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The position supports operational needs and activities in order to successfully achieve quality goals and complaints metrics.

Core Responsibilities

• Handles product complaints received from customer service department.
• Initiates, process and send notifications as required by applicable Standard Operating Procedures (SOPs).
• Interacts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint.
• Evaluate complaints for regulatory reportability and create and submit reports that comply with applicable regulations.
• Writes, investigates and ensures timely submission of complaints investigation.
• Reviews and approves complaint investigation submitted by other team members.
• Collaborates with other departments to ensure technical issues are being addressed and investigations are conducted thoroughly.
• Initiates applicable Corrective Action/Preventative Action (CAPA) plans.
• Accurately maintain product complaint logs (softcopy and hardcopy) through internal database tracking system and complete all filing and closing procedures as required by applicable Standard Operating Procedures (SOPs)

• Responsible for ensuring that paperwork is complete for each complaint folders.
• Perform other duties and assume responsibilities as appropriate or assigned.

Qualifications & Requirements

• Bachelor’s degree required, preferably life sciences
• 2+ years of experience in pharmacy operation or experience in cGMP environment
• Must be able to facilitate collaboration, while knowing when to move to end analysis and recommend decisions
• Strong written, verbal and presentation communication skills
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) required
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards

Position Type

• On-Site

Travel

• None

The hours for this role are 3pm to 1:30am

Job Summary

This position will ensure that the operations follow the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The QA Manufacturing Specialist will provide Quality oversight of the Manufacturing and Production areas, including compounding, filling, inspecting, and labeling/packaging. Management includes the periodic review of in-process activities such as cleaning, weighing, aseptic filling, material status verification, compounding, batch record documentation accuracy, logbook documentation accuracy, and room/line clearances. 

Core Responsibilities

• Provides Quality oversight of Production activities, including compounding, aseptic filling, inspection, and labeling/packaging on the floor.
• Provides Quality oversight of cleaning activities to ensure compliance with cleaning requirements. 
• Product label review and approval. 
• Oversight and confirmation compliance with Filling Operations, including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms, and batch records. 
• Verification of proper gowning by all personnel in all areas of Production.
• Generation of deviations, issuance of CAPAs, and Change Controls in response to observations.
• Oversee all Quality aspects on the floor.
• Participate in regulatory audits if required. 
• Performs or assists process owners with the root cause analysis.
• Responsible for generating deviations and change controls when required. 
• Performs duties following established company procedures and policies; performs other duties as assigned.

Qualifications & Requirements

• 3-5 years of progressive experience in cGMP quality operations and FDA regulations, a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment, or equivalent technical experience.

• High school degree
• BS in the Scientific field preferred

• Three-plus years of experience with aseptic drug product manufacturing is required.
• A fundamental, working knowledge of safety, quality systems, and quality assurance concepts are required, including the application of current Good Manufacturing Practices and Good Documentation Practices.
• Strong familiarity with manufacturing processes, operations, automation, and equipment/facilities.
• Ability to complete tasks with little direction or need for supervisory follow-up.
• Strong written, verbal, and presentation communication skills.
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and others must be able to learn additional software as required).
• Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
• Work schedule flexibility. 

The hours for this shift are 10am - 6:30pm

Job Summary

The Warehouse Associate performs all functions necessary to ensure the accuracy, organization, and cleanliness of all warehouse space and operations. Ensuring all production orders are staged and ready for manufacturing. The candidate will participate in all inventory cycle counts, document and investigate inventory discrepancies, and perform reconciliations.  

Core Responsibilities

• Identifies the root cause of inventory discrepancies. 
• Ensures materials are received in the correct locations. 
• Participates in weekly, quarterly and annual physical inventory counts.
• Works with Pharmacy/Production staff to ensure FIFO is enforced.
• Notifies the Logistics / Warehouse Supervisor of shortages or other problems that could impact product availability.
• Ensures all activities performed are done so in compliance with all corporate/site policies.
• Notifies the Warehouse Supervisor of any defects related to purchased goods promptly.
• Perform other duties and assume responsibilities as appropriate or assigned.

Qualifications & Requirements

• Requires High School or GED or a combination of education and experience.
• 3+ years of experience in Warehouse inventory management preferred.
• Experience with ERP systems preferred.
• Experience in a cGMP-regulated manufacturing environment preferred.
• Understand planning policies and procedure
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) preferred.
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards while being a team player.

Job Summary

The Environmental Monitoring Technician will perform environmental monitoring and routine microbiology testing within a GMP drug manufacturing organization.

Core Responsibilities

• Perform routine environmental monitoring (EM: non-viable particulates, air viable, surface, and personnel) in cleanroom environments.
• Maintained the microbiology laboratory, including monitoring equipment function, for example, temperatures of QC incubators. 
• Perform reads on media fill samples.
• Collect Water for Injection (WFI) and pre-treatment water samples throughout the manufacturing facility and perform microbially, TOC, and conductivity testing of samples.
• Incubate and read EM plates and document results on relevant forms.
• Send the plates for Microbial ID to a third-party lab. 
• Trend data for EM and water samples and assist with preparing quarterly EM reports.
• Manage routine monitoring of other facility utilities, including compressed air.
• Manage sample chain of custody for raw material, finished goods, and sterile components with third-party laboratories. 
• Managers retain a sample chain of custody.
• Responsible for initiating, investigating, and writing deviation.
• Manage gown qualification program.
• Performs other Quality duties as required, including the execution of the sample management program. 

Qualifications & Requirements

• Prefer a Bachelor's degree (B.S.) in Microbiology or Biology and 3-5 years of sterile pharmaceutical manufacturing plant experience. 
• Ability to apply knowledge of good manufacturing practices and good laboratory practices daily.
• Understanding and ability to perform aseptic and relevant microbiological techniques.
• Ability to follow gowning practices for cleanroom environments.
• Must be a team player.
• Monitors own work to ensure quality.
• Completes work promptly.
• Adapts to changes in the work environment.
• Willing to work additional hours when required and works on weekends when necessary to reach goals.
• Completes tasks on time or notifies the appropriate person with an alternate plan.

Job Summary 

 HOURS - 3:00PM - 1:30AM

The Maintenance Mechanic will be responsible for maintaining manufacturing, filling equipment, facilities and utilities following Standard Operating Procedure. Under the direction of the Facilities and Maintenance Manager, the Maintenance Mechanic will support operations and other departments for day-to-day manufacturing activities working within classified areas on a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include maintenance of HVAC, Water System, Manufacturing and Filling Equipment.  

Core Responsibilities 

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) 

• Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including boilers, air compressors, heating, ventilation and air conditioning systems (HVAC), Water for Injection (WFI), and general upkeep of the physical plant including clean rooms. 

• Perform manufacturing and facility equipment maintenance, installations and repairs as needed including but not limited to electrical, plumbing, and light construction. 

• Assist with development and documentation of preventative maintenance and calibration program for production equipment including clean room and utilities. 

• Document preventive maintenance, reactive maintenance and calibration events on company deployed computerized maintenance management system (CMMS). 

• Coordinate services with outside vendors for calibration and routine maintenance. 

• Perform execution of equipment installation and qualification. 

• Deploy 5S strategies in the setting up and maintenance of spare parts inventory utilizing CMMS software. 

• Monitor facilities and manufacturing operating equipment daily, troubleshooting problems and inefficiencies and recommending possible solutions. 

• Supports continuous improvement by completing work on time, identifying potential issues, and driving to improve work processes and procedures relative to manufacturing and/or filling and packaging equipment. 

• Provide after-hours support and/or weekend emergency service. 

• Perform continuous training assignments within the allotted time schedule. 

Qualifications & Requirements 

• Must have experience in a cGMP regulated environment and have worked in a medical device or pharmaceutical manufacturing facility. 

• Minimum of 2 - 3 years previous experience in a medical device or pharmaceutical manufacturing preferably in a clean room environment. 

• Must be familiar with machine controls including Programmable Logic Controllers (PLCs), relay logic, and operator interfaces. 

• Must be comfortable working on and troubleshooting low voltage (DC) as well as high voltage (120VAC) systems. 

• Must be familiar with plant utility systems compressors and HVAC. 

• Strong technical ability and mechanical aptitude to troubleshoot and repair equipment malfunctions. 

• Must be able to provide after-hours support and/or weekend emergency service support. 

• Demonstrated ability to effectively maintain, troubleshoot, and repair industrial equipment involving technical and mechanical issues (i.e. equipment adjustments, parts replacement). 

• Requires a demonstrated mechanical and technical aptitude in order to problem-solve effectively. 

• Ability and willingness to work and participate effectively in a team environment.  

• Ability and willingness to maintain accurate and factual hard copy and electronic records. 

• Attention to detail, safety, quality and customer requirements. 

• Ability to effectively communicate verbally and in writing to peers and management. 

• Ability to read information and apply what is described in the reading material to situations that may contain several details or describe processes involving several steps. 

• Demonstrate high level of personal motivation and initiative. 

Position Type  

• On-Site 

Travel 

• None 

The hours for this role are 3pm - 1:30am

Job Summary

The Production Sterilization Specialist will be responsible for conducting labeling, packaging, and production support activities to support commercial manufacturing. Under the direction of the Production Supervisor/Team Leader, the Production Support Associate will work hands-on under ISO7, ISO8, and other classified areas with various manufacturing production equipment and technologies. Daily responsibilities vary, including operating cleaning machines and preparing supplies for manufacturing by cleaning and disinfecting. 

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.
• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any workplace hazards, unsafe acts, or conditions.
• Accurate completion of product documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Excellent organization and time-management skills are required. Must promptly manage a heavy workload and aggressive timelines, prioritize, and work under pressure.
• Cleaning, sanitizing, and disinfection of equipment and components required for production. 
• Works with the Warehouse Department to ensure all components are available ahead of time for production. 
• Completes all necessary cleaning and sanitizing of production equipment and area.
• Stages material for production use.
• Operation of cleaning equipment including but not limited to Autoclave, Fedegari, and Depyrogentation oven.
• Performs calibration of check weighing.

Qualifications & Requirements

• High School Diploma or equivalent work and education in a related field are required.
• 1-3 years of experience working in the pharmaceutical industry and within aseptic clean room environments.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Ability to handle sensitive information with a high degree of confidentiality.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Proficient in using standard Microsoft Office software products, including Excel, Outlook, and Word.
• Strong organizational skills with the proven ability to prioritize.
• Works with a sense of urgency while engaging and listening to experts.

The hours of this shift are 3pm - 1:30am

Job Summary

The Warehouse Associate I performs all functions necessary to ensure the accuracy, organization, and cleanliness of all warehouse space and operations. Ensuring all production orders are staged and ready for manufacturing. The candidate will participate in all inventory cycle counts, document and investigate inventory discrepancies, and perform reconciliations.  

Core Responsibilities

• Identifies the root cause of inventory discrepancies. 
• Ensures materials are received in the correct locations. 
• Participates in weekly, quarterly and annual physical inventory counts.
• Works with Pharmacy/Production staff to ensure FIFO is enforced.
• Notifies the Logistics / Warehouse Supervisor of shortages or other problems that could impact product availability.
• Ensures all activities performed are done so in compliance with all corporate/site policies.
• Notifies the Warehouse Supervisor of any defects related to purchased goods promptly.
• Perform other duties and assume responsibilities as appropriate or assigned.

Qualifications & Requirements

• Requires High School or GED or a combination of education and experience.
• 3+ years of experience in Warehouse inventory management preferred.
• Experience with ERP systems preferred.
• Experience in a cGMP-regulated manufacturing environment preferred.
• Understand planning policies and procedure
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) preferred.
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards while being a team player.

Job Summary 

 HOURS ARE 9:00 am - 7:30pm

The Production Visual Inspection Technician Level 1 will be responsible for conducting visual inspections of vials for cosmetic and physical defects to support manufacturing. Under the direction of the Production Supervisor, the Visual Inspector will work hands on, under ISO7, ISO8 and other classified areas with a variety of manufacturing production equipment and technologies. Dally responsibilities vary. 

Core Responsibilities 

• Ensures that all work Is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). 

• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning and working in the sterile and controlled areas. 

• Reports any accidents, Incidents and Injuries or Illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace. 

• Accurate completion of production documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements. 

• Knowledge of current Good Manufacturing Practices (cGMP) guidelines. 

• Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure. 

• Performs visual Inspection of vials for cosmetic and physical defects. 

• Responsible for classification of defects observed during the Inspection as per related procedures. 

• Must have close visual acuity to notice errors and/or defects and attention to detail. 

• Inspector qualification for visual Inspection of injectables for a length of 8 hours. 

• Inspector qualification for visual inspection of solution products. 

• Manual dexterity and the ability to perform repetitive motions with accuracy are required, 

• Report abnormalities and deviations in a timely and accurate manner, 

• Contributes to Quality activities such as supporting investigations, corrective actions, and area walk-throughs. 

• Ability to work as part of a high-performing team and collaborate effectively with staff. 

Qualifications & Requirements 

• High School Diploma or equivalent work and education in a related field, required, 

• 1-2 years of visual Inspection experience. 

• Ability to work Independently. 

• Ability to handle sensitive Information with a high degree of confidentiality. 

• Basic math skills 

• Proficient In the use of standard Microsoft Office software products, including Excel, Outlook, Word. 

• Strong organizational skills with the proven ability to prioritize, 

• Works with a sense of urgency, while engaging and listening to experts. 

• (20/20) vision with corrections. 

Position Type  

• On-Site 

Travel 

• None