QC Analyst in Emeryville, CA at Apex Life Sciences

Date Posted: 10/5/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a new candidate to provide expertise to their designated QC group, and to accurately assess the purity, potency, efficacy, and other performance characteristics for the purpose of supporting both manufacturing and quality assurance in the production. This individual will help release and monitor established product lines.

  • Perform assays for their designated laboratory: final product (antigens) protein chemistry, microbiological testing for release of product
  • Routine testing for release of Raw Materials, Seed Stock Antigen Stability, reference/reagent qualification testing Seedstock Stability testing.

Skills:

  • Must have one or more assay testing experience in one of the main areas listed: Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits.
  • Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.
  • Bacterial and Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
  • Environmental/Utility/facility Monitoring testing such as: 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 such as Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or complendial test methods
  • Assay trouble shooting experience in their expert area Pharmacoepeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color and appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter.

Education:

  • Bachelor’s degree in Biochemistry, Molecular Biology, Immunology At least 1-2 years’ experience in a regulated GMP testing laboratory
     

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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