Associate Director, Quality Control from Joulé
Exton, PA
About the Job
Job Title: Associate Director Quality Control
Location: Exton, PA
Type: Contract to hire
Schedule: Monday - Friday Day Hours
Responsibilities:
Requirements:
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
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