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 ethics & compliance guidelines.
Must meet the two (2) mission critical competencies:
- Customer Focus