Senior Quality Control Manager

1 week ago


Exton, Pennsylvania, United States Joulé Full time
Job Summary:

We are seeking a highly experienced Senior Quality Control Manager to lead our Quality Control team. The ideal candidate will have a strong background in Quality Control, with a minimum of 10 years of experience in the biologics industry. The successful candidate will be responsible for managing a staff of Quality Control analysts and Environmental Monitoring specialists, ensuring that day-to-day scheduling of activities is appropriately resourced.

Key Responsibilities:
Manage laboratory equipment upkeep, calibration, and preventive maintenance
Ensure all method qualification and validation is current
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
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)

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

About Joulé:
Joulé is a leading provider of staffing solutions for the life sciences industry. We are committed to delivering exceptional service and expertise to our clients and candidates. If you are a motivated and experienced Quality Control professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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