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Specialist, Quality Control
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- Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using analytical techniques such as potency, PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC- ELSD, HPLC-MS), spectrophotometry, AUC, and electrophoresis (CE, PAGE, western blotting).
- Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
- Performs trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
- Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
- Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years of experience in pharmaceutical industry or equivalent or 4 years of experience at GTx.
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