Company Description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, a place to call home, apply with us today!

Job Description

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 in-process samples, manufactured Bulk Drug Substance and Drug Product lots.

Job Responsibilities:

• Manage a staff of Quality Control analysts ensuring that day-to-day 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 phase-appropriate 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 cGMP’s.
• 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 and 211, 600, 21 CFR 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 goal-based bonus & eligibility for merit-based increases

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