Quality Assurance Manager

4 weeks ago

Exton, Pennsylvania, United States Joulé Full time
Job Title:
Quality Control Manager

Job Summary:
We are seeking a highly experienced Quality Control Manager to join our team at Joulé. 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 and ensure proper documentation in logbooks and electronic management systems.
• Ensure all method qualification and validation is current, including bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays.
• 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 and 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 and 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 and 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.

What We Offer:
• Competitive salary and benefits package.
• Opportunity to work with a high-energy team in pursuit of organizational goals and strategies.
• Professional development and growth opportunities.
• Collaborative and dynamic work environment.

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