QC Scientist Group Leader

General Description:

Supervise the Quality Control functions executed by a small team and provide direct support of Quality Control processes test procedures and procedure validation activities. Measure generate and evaluate data for the Certificates of Analysis to support testing of inprocess samples manufactured Bulk Drug Substance and Drug Product lots.

Job Responsibilities:

• Manage a staff of Quality Control analysts ensuring that daytoday scheduling of activities is appropriately resourced.
• Maintain raw material release testing program.
• Manage laboratory equipment upkeep calibration and preventive maintenance and ensure proper documentation in logbooks and electronic management systems.
• Ensure all method qualification or validation is current. Test procedures include bioassay methods binding assays flow cytometry gene expression analysis and microbial control assays.
• Keep apprised of compendial changes and ensure compliance with compendia for all test procedures.
• Manage external vendors providing lab services and materials.
• Maintain laboratory housekeeping including organization cleanliness and logbooks.
• 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 phaseappropriate specifications.
• Ensure data integrity is maintained for all applications programs and executed work. Ability to document all work using Good Documentation Practices and ALCOA principles.
• Generate protocols and technical reports.
• Author and manage QC change controls test procedure revisions SOP and ATM revisions laboratory investigations and root cause analyses.
• Raise critical quality issues to upper management.
• Perform internal audits to ensure compliance with cGMPs.
• Write and revise Quality Systems SOPs as necessary to maintain compliance.
• Train and develop employees.
• Ensure full compliance with applicable health and safety regulations (such as OSHA).

Qualifications :

Basic Minimum Qualifications:

• BS in a scientific discipline
• Minimum 10 years of Quality Control experience in GMP environment in the biologics industry with a minimum of 3 years direct management experience in Quality Control
• Excellent knowledge of cGMP guidelines USP/NF 21 CFR Parts 210 andCFR Part 11 and other regulatory standards
• 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

Additional Information :

Position is Full Time First Shift some evening and weekend work may be required as needed. Candidates currently living within a commutable distance of Exton PA are encouraged to apply.

What we offer:

• Excellent full time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goalbased bonus & eligibility for meritbased increases

Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.

Remote Work :

No

Employment Type :

Fulltime