QA Associate I
1 DNA Way South San Francisco, CA 94080 | Contract
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.
- 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
- 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