Associate Stability Research Scientist, GMP Pharmaceuticals
Overview
You will run the stability program for commercial and development-stage products at a GMP-regulated pharmaceutical site. You own sample inventory, testing schedules, and equipment monitoring across 20+ active studies. You work with QC, Manufacturing, and Packaging to keep studies compliant. This contract role in Clayton, NC is your chance to deepen regulatory expertise. You will drive data integrity and prevent compliance gaps.
What You'll Do10
- 1Maintain stability sample inventory for 20+ studies with accurate documentation and chain-of-custody.
- 2Coordinate sample acquisition, storage, tracking, and delivery for testing across QC and Manufacturing.
- 3Generate and review monthly stability schedules, then release samples for assigned time points.
- 4Remove samples at study completion and archive all related records per GMP guidelines.
- 5Track and fulfill internal requests for extra stability samples, including biological shipments between sites.
- 6Audit stability records, labels, and documentation to ensure GMP compliance and data integrity.
- 7Conduct investigations on sample, labeling, or inventory discrepancies and document root cause.
- 8Monitor stability chambers, incubators, and freezers daily, tracking temperature and humidity trends.
- 9Initiate work orders for preventive maintenance and qualify equipment after repairs.
- 10Enter stability data into SAP or validated databases and reconcile with lab results.
Requirements10
- 11-2 years in a GMP regulated pharma, biotech, or biologics environment.
- 2Bachelor's degree in Biology, Chemistry, Biochemistry, or Pharmaceutical Sciences (or Master's with no experience).
- 3Hands-on with ICH stability guidelines and GMP documentation practices.
- 4Proven sample management or inventory control in a lab setting.
- 5Detail-oriented with skill in investigating and documenting deviations.
- 6Strong written and verbal communication for cross-functional reports.
- 7Proficiency in Microsoft Office (Excel, Word, Outlook) for data tracking.
- 8Familiarity with SAP, Maximo, DeltaV, or LabWatch systems.
- 9Experience shipping biological samples and following chain-of-custody.
- 10Background in visual inspection or vial integrity testing is a plus.
Salary Insight
$30k per year
Location
Required Skills
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