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Scientific. Clinical. Software Engineering

Senior QC Analyst

Oakland-Fremont-Pleasanton Metro Area, CA

Job Type: Scientific Job Number: JN -052019-24824 Region: Oakland-Fremont-Pleasanton Metro Area

Job Description

  • 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
  • Function/TechnicalSkills
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