QC Associate Scientist

Astrix; Kentucky; On-site; USD 75,000 - 90,000; Full time

Job summary

A leading contract manufacturer is seeking a skilled QC Associate Scientist to join their team in Lake County, OH. This role will support a GMP-regulated API analytical laboratory, performing routine and non-routine analytical testing, as well as method transfers. Ideal candidates will possess a Bachelor’s degree in Chemistry or a related discipline, along with a minimum of 5 years experience in a pharmaceutical analytical lab. Strong expertise in HPLC and GC analysis is essential for collaboration within a cross-functional team.

Qualifications

• Minimum of 5 years of experience in a pharmaceutical analytical laboratory.
• Strong hands-on experience with HPLC and GC.
• Experience in cGMP/GLP environments.

Responsibilities

• Perform routine HPLC and GC analyses.
• Conduct additional analytical techniques as required.
• Review analytical data for technical accuracy.

Skills

HPLC expertise

GC analysis

Analytical chemistry principles

Collaboration and teamwork

Education

Bachelor’s degree in Chemistry or related discipline

Tools

HPLC

GC instrumentation

Balances

Pipettes

pH meters

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! *