QC Analyst, 2nd Shift Representative
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), analytical methods, current Good Manufacturing Practices (cGMPs), and regulatory requirements. The role requires a clear understanding of Good Laboratory Practices (GLPs), cGMPs, and other applicable regulatory requirements. The analyst contributes to continuous improvement of processes and procedures, uses judgment to select methods and evaluate results, and appropriately escalates issues to QC management. The position supports clinical and commercial testing and requires direct communication with management. The position is full-time, Monday through Friday, with a choice of shift hours: 1:30 p.m. to 10:00 p.m. or 2:30 p.m. to 11:00 p.m. Travel is not required. The stated full-time equivalent pay range is $34.00–$53.13 per hour, with eligibility for bonus, stock, and benefits.
Requirements
- Bachelor's or Master's degree, or equivalent.
- At least 2 years of experience in a laboratory, HPLC, UV, bench-top, or wet chemistry setting.
- Clear understanding of Good Laboratory Practices (GLPs), cGMPs, and other regulatory requirements.
- Outstanding written and oral communication skills.
- Post-graduate qualification, certification, and/or license may be required.
Responsibilities
- Conduct routine and non-routine analysis and review to support in-process testing in accordance with SOPs, analytical methods, cGMPs, and regulatory requirements.
- Conduct analysis associated with clinical and commercial work under applicable GMP regulations and guidance, including FDA, OECD, and international regulations.
- Analyze in-process samples (developmental and commercial), raw materials, and other requested testing according to written procedures.
- Review data for compliance with specifications and reports, and troubleshoot abnormalities.
- Ensure equipment is performing well, communicate issues, and take appropriate action as necessary.
- Follow good documentation practices.
- Engage in continuous improvement of processes and procedures.
- Exercise judgment in selecting methods, techniques, and evaluation criteria to obtain results.
- Communicate effectively in writing and orally, including directly with management.
- Escalate issues to QC management as appropriate.
Benefits
- Eligibility for bonus, stock, and benefits (specific benefits not listed).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
