Job Description

Our client, a leading contract manufacturer and research organization for 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 – $90,000 per year DOE

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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