Overview In this role you will lead the Quality Control Analytical Laboratory's testing and review activities, ensuring GMP-compliant analysis of raw materials, in-process, and finished products. You will drive peer reviews, investigate OOS events, and communicate with clients on quality issues, while supporting test methods and SOPs. You'll collaborate with QA/QC and operations to maintain high standards and ensure reliable analytics. This position offers a chance to shape the QC function within a global biopharma services environment.
Responsibilities- Prioritize and assign tasks to QC analysts
- Investigate OOS and customer complaints
- Perform peer review of analytical work
- Train new employees
- Conduct routine analytical testing of raw materials, in-process samples, and finished products
- Perform tests using HPLC, Karl Fischer, Particle Size Analyzer, UV-Vis, Densitometer, Osmometer, and other required instruments
- Calibrate instruments and perform preventive maintenance
- Document work in CGMP-compliant lab records
- Write, review, and update SOPs
- Handle other duties as needed
- Communicate with clients regarding quality events
Key requirements- 5+ years of analytical chemistry experience in pharmaceutical QC
- Experience in a cGMP laboratory
- Experience in a CMO (preferred)
- Leadership experience (preferred)
- Bachelor of Science in a scientific area of study
- Master of Science in a scientific area with 3+ years of QC/analytical experience (preferred)
- Ability to prioritize tasks for staff and make informed decisions
- Detail oriented with strong communication and organizational skills
- Office Suite experience (Excel, Word, Access, PowerPoint)
- strong oral and written communication
- excellent organization and multitasking
- resilience and ability to adapt to changing priorities
- HPLC
- Karl Fischer
- Particle Size Analysis
