Senior QC Analyst
Oakland-Fremont-Pleasanton Metro Area, CA
Use experience in all analytical assay method training to coordinate & perform critical material qualification & maintenance and/or other projects that are in addition to typical release, reference/reagent qualification and/or stability testing.
To provide expertise to their designated QC group & to accurately assess the purity, potency, efficacy & other performance characteristics for the purpose of supporting both manufacturing & quality assurance in the production, release & monitoring of established product lines
Coordinate & perform assays for their designated laboratory
Routine in-process, final product (antigens) protein chemistry testing for release of product
Routine in-process, final product (antigens) microbiological testing for release of product
Routine testing for release of Raw Materials
Routine testing for release of Seed Stock
Antigen Stability, reference/reagent qualification testing
Seedstock Stability testing
Cleaning & or Process Validation testing
Analytical Method Validation testing
Product/Method development testing
Use experience & method expertise to conduct troubleshooting
May be assigned to assist with OOS Investigations,
May be assigned to work independently on Validation, & Technical studies
May be assigned to assist with the planning & execution of OE projects
May be assigned to train staff on test methods
Comply Site Environmental Health & Safety (EH&S) requirements
Must have substantial (3 or more) assay testing experience in one of the main areas listed below:
Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's & in vitro diagnostic test kits.
Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing & Growth Promotion.
Bacterial & Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity & phenotype testing, DNA Plasmid isolation & restriction digest testing.
Environmental/Utility/facility Monitoring testing such as Sampling of & testing of manufacturing water by membrane filtration, viable & non-viable particulate testing of facilities & utilities, viable (surface) monitoring of manufacturing facilities, personnel & biological hoods, moisture & oil content testing of compressed gases
Analytical/Microbiological Method Validation testing such as Bacteriosis & Fungistasis, linearity, specificity & 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 & appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
Proficient in MS Word, MS PowerPoint & MS Excel software
Must be familiar with GMP's & Quality System Regulations (QS Regs)
Must have good time management, effectively prioritizing tasks for completion
Individual must work in an ethical manner & ensure employees follow company ethics & compliance guidelines.
Bachelor s degree in Biochemistry, Molecular Biology, Immunology with 3 years experience or, MS degree in Science with 1 plus years experience
At least 3 years experience in a regulated GMP testing laboratory
NOTE: Notification of Hep B vaccination required.