Quality Control Analyst
About The Position
The Quality Control Analyst conducts routine and non-routine analysis and review to support in-process testing, following Standard Operating Procedures (SOPs) and analytical methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. The role requires a clear understanding of Good Laboratory Practices (GLPs), cGMPs, and other regulatory requirements, and contributes to continuous improvement of processes and procedures. The analyst exercises judgment, escalates issues appropriately to QC management, and communicates directly with management. The position supports clinical and commercial operations by analyzing in-process samples, raw materials, and other requested samples, reviewing data for compliance with specifications, troubleshooting abnormalities, and ensuring equipment is performing properly. Work must follow written procedures and good documentation practices. The position is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m. It is full-time, with no travel required and no stated end date.
Requirements
- Bachelor's degree (B.S.) in Chemistry or a related life sciences field.
- 2–5 years of relevant industry experience.
- Exposure to and knowledge of FDA regulations and guidelines.
- Knowledge of cGMP guidelines or international regulations, such as ICH Q7.
- Knowledge of analytical equipment and instrumentation used to test in-process samples.
- Proficiency with Microsoft Word and Excel.
- Outstanding written and oral communication skills.
Nice To Haves
- Familiarity with Chemstation.
- Familiarity with UV analysis.
- Familiarity with HPLC.
- Familiarity with HPLC-MS.
- May require cross-training to support raw material and microbiological testing.
- May require handling highly potent API material.
Responsibilities
- Conduct routine and non-routine analyses and reviews to support in-process testing according to SOPs and analytical methods.
- Conduct analyses associated with clinical and commercial work under applicable GMP regulations and FDA, OECD, and international guidance.
- Analyze developmental and commercial in-process samples, raw materials, and other requested samples according to written procedures.
- Review data for compliance with specifications and reports, and troubleshoot abnormalities.
- Ensure equipment is performing properly and communicate and take appropriate action when needed.
- Follow good documentation practices.
- Contribute to continuous improvement of processes and procedures.
- Exercise judgment in selecting methods, techniques, and evaluation criteria, and escalate issues appropriately to QC management.
- Communicate effectively, including directly with management.
Benefits
- Eligibility for bonus, stock, and benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
