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QC Analyst

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 10/03/2018 Job Type: Scientific Job Number: JN -102018-22731
Accurately assess the purity, potency, efficacy, and other performance characteristics for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines.

  • Must have one or more assay testing experience in one of the main areas listed:
    • Protein chemistry:
      • Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits.
    • Microbiological methods:
      • Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.
    • Bacterial and Yeast Seedstocks testing methods:
      • Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
    • Environmental/Utility/facility Monitoring testing:
      • Sampling of and testing of manufacturing water by membrane filtration, viable and non-viable particulate testing of facilities and utilities, viable (surface) monitoring of manufacturing facilities, personnel and biological hoods, moisture and oil content testing of compressed gases
    • Analytical/Microbiological Method Validation testing:
      • Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or complendial test methods
    • Pharmacoepeial (compendial) test methods for Raw Materials:
      • melting point, loss on drying, color and appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
  • Bachelor's degree in Biochemistry, Molecular Biology, Immunology
  • At least 1-2 years' experience in a regulated GMP testing laboratory
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