QA Analyst I

South San Francisco, CA 94080

Posted: 09/20/2018 Employment Type: Contract Industry: Quality Job Number: 4840

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • The job responsibility within the Biological Technologies in Analytical Development and Quality Control is to develop, validate, and perform biochemical/immunological/biophysical and cell-based assays in support of process development, clinical and to-be-marketed products.
  • The candidate will support process development, product characterization, stability, and lot release testing with established procedures in a cGMP environment.
  • Responsibilities include participating in the development and/or validation of potency assays, compliance review of assay packets and release of assay data, preparing assay reagents, generating computer results, and monitoring assay quality.
  • Expectations include use of Labware LIMS, EDMS DocLink, and maintenance of labs via Lean tools such as 5S and Environmental, Health, and Safety practices, routine lab maintenance, and project support/equipment qualification/computer systems/document management as needed.

 

 

Skills:

  • Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative, strong attention to detail, with effective verbal and written communication skills for a fast paced environment is a must.
  • Must also be dependable and able to work with minimal supervision.
  • Familiarity with basic laboratory equipment is preferred.
  • Experience with performing immunological or cell-based assays, aseptic cell culturing, DOE/familiarity with JMP analysis, reporter assay, and cGMP familiarity/knowledge a plus.
  • Good computer skills are required, and experience working with Labware LIMS, EDMS ConDor, and Trackwise are recommended.
  • Hands-on routine experience with performing immunological or cell-based assays is a plus.
  •  Experience with ELISA, aseptic cell culturing, DOE/familiarity with JMP analysis, reporter assay, and cGMP familiarity/knowledge a plus.
  • Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative, strong attention-to-detail, with effective verbal and written communication skills for a fast paced environment is a must.
  • Good computer skills are required, and experience working with Labware LIMS, EDMS DocLink, and Trackwise are recommended.

 

Education:

  • B.S. in Biological Sciences. 1-2 years of relevant experience in Quality Control, preferred.
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