QA Associate I

South San Francisco, CA 94080 | Contract

Post Date: 07/23/2018 Job ID: 4516 Industry: Quality

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:      
  • Collect data from multiple QC labs and coordinate any corrections.
  • Scan Lot Release, Reference Material, Cell Bank into validated system.
  • Manage the archival of lot release, tox lots, and CMO data
  • Maintain database for all documents received.
  • Coordinate the preparation and retrieval of data to and from offsite storage location.
  • Receive, manage, and distribute Clinical Sampling Plans, Protocols, Memos, CMO CoAs, Testing Request Forms.
  • Manage and drive to completion requests from different QC groups.
  • Compile analytical data for bulk, final product.
  • Adhere to cGMP compliance guidelines.
  • Support internal and external audits (as needed).
  • Accomplish corporate, operational and departmental goals
  • Apply expertise of compliance requirements to maintain an inspection-ready state.
  • Train personnel on relevant business processes.
  • Provide data and documents to support product quality impacting investigations

 

 

Job Requirements:

  • B.S in Physical, Life Science, or related field
  • GMP experience preferred with particular emphasis on Quality Control
  • Experience working with Labware LIMS, SAP and Trackwise are preferred
  • Ability to communicate clearly and professionally both in writing and verbally
  • Flexibility in problem solving
  • Ability to work independently as well as within a team
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