Job Title: Quality Control Manager

Location: Exton, PA

Type: Contract to hire

Schedule: Monday - Friday Day Hours

Responsibilities:

• Manage a staff of Quality Control analysts and Environmental Monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourced

• Maintenance of the viable and non-viable Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order status

• Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems

• Ensure all method qualification and validation is current. Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays (additional analytical platforms maybe implemented as per business needs)

• Keep apprised of compendial changes and ensure compliance with compendia for all test procedures

• Manage external vendors providing lab services and materials

• Maintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budget

• Ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final Drug Product

• Participate in the establishment of phase-appropriate specifications

• Ensure data integrity is maintained for all applications, programs, and executed work

• Generation of protocols, technical reports, and other documentation as needed

• Author and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations, root cause analyses, and risk assessment as needed

• Raise critical quality issues to upper management

• Perform internal audits to ensure compliance with cGMP’s

• Write and revise Quality Systems SOPs and other documentation as necessary to maintain compliance

• Training and development of employees

• Support audit of external parties and regulatory inspections

• Ensure full compliance with applicable health and safety regulations (such as OSHA)

• Willingness to engage with a high energy team in pursuit of organizational goals and strategies

  Requirements:

• Minimum Bachelor of Science degree in a relevant scientific discipline

• Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality Assurance

• Excellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards

• Technical writing experience in a similar role in the biologics or pharmaceutical industry

• Experience in aseptic processing and/or mammalian cell culture production

• Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills

• Ability to prioritize and successfully execute multiple tasks simultaneously

• Ability to work with a high degree of accuracy and detail

• Positive work attitude that supports teamwork and continuous improvement

  #M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.