Description
Perform qualitative and quantitative analyses of raw materials, in-process samples, and finished products to verify compliance with specifications and regulatory requirements. Use chromatographic, spectroscopic, and wet-chemistry methods under cGMP to support release, stability, and investigations.
- • Analyze raw materials, in-process samples, and finished goods for identity, potency, purity, and impurities using HPLC, GC, ICP, UV-Vis, and wet chemistry.
- • Execute routine QC tests per compendial and internal specifications, including dissolution, moisture, pH, and titrations.
- • Prepare, standardize, and label reagents, standards, and mobile phases for testing.
- • Maintain, calibrate, and troubleshoot laboratory instruments and perform system suitability checks.
- • Document results in LIMS and laboratory records with cGMP-compliant data integrity; generate certificates of analysis.
- • Compile, trend, and review analytical data to assess process control and product stability.
- • Participate in OOS, OOT, deviation, and complaint investigations; support root cause analysis and CAPA.
- • Author, revise, and follow SOPs, test methods, and specifications; support method verification, validation, and transfer.
- • Coordinate sampling plans and collaborate with QA and manufacturing on batch release and change controls.
- • Conduct quality control checks and ensure compliance with GMP, GLP, and ISO requirements; maintain audit readiness.
- • Manage inventory of chemicals, reference standards, and consumables; track expirations and storage conditions.
- • Train and mentor laboratory personnel in QC procedures and good documentation practices.
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Related Pathways
Advanced Manufacturing
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
