Our client, a leading contract manufacturer and research organization of API's, is looking for a skilled QC Associate Scientist to join their team in Lake County, OH!
Location: Lake County, OH
Salary: $75,000 - $80,000 per year
Employment Type: Full-time
Position Summary The QC Associate Scientist will support a GMP-regulated API analytical laboratory by performing routine and non-routine analytical testing, method transfers, and investigations. This role requires strong expertise in HPLC and GC analysis, experience working within cGMP environments, and the ability to collaborate cross-functionally to support project timelines and quality objectives.
Responsibilities - Perform routine HPLC and GC analyses in a GMP API analytical laboratory.
- Execute and support GMP analytical method transfers, including preparation of transfer protocols and final reports.
- Conduct additional analytical techniques as needed, including but not limited to: FTIR, IC, Karl Fischer (KF), XRD, NMR, DSC, TGA, particle size analysis, Titrations, UV-Vis spectroscopy, and optical rotation.
- Coordinate release testing for raw materials, intermediates, and active pharmaceutical ingredients (APIs).
- Perform out-of-specification (OOS) investigations and support root cause analysis.
- Ensure timely and compliant generation of analytical data to meet project and regulatory timelines.
- Review analytical data for technical accuracy and adherence to good documentation practices.
- Maintain compliance with cGMP, GLP, and laboratory safety requirements.
- Collaborate effectively with Quality Assurance, Production, and Technical teams.
- Perform other duties as assigned.
Qualifications - Bachelor's degree (B.S.) in Chemistry or related scientific discipline required.
- Minimum of 5 years of experience in a pharmaceutical analytical laboratory or equivalent combination of Strong hands-on experience with HPLC and GC instrumentation.
- Proficient with standard laboratory equipment (balances, pipettes, pH meters, etc.).
- Solid understanding of analytical chemistry principles and laboratory safety practices.
- education and experience.
- Demonstrated experience working in cGMP/GLP environments, including QC or stability testing.
- Experience interacting with Quality Assurance and regulatory documentation.
*This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! *
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