QA Analyst I

South San Francisco, CA 94080 | Contract

Post Date: 06/20/2018 Job ID: 4401 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:
  • Perform testing of routine and non-routine samples and document according to GMP
  • Perform environmental monitoring and utilities sampling and document according to GMP
  • Review data and assess against established acceptance criteria Perform technical review of peer-generated data for basic methods
  • Prepare data tables and graphs Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
  • Receive and provide training
  • Participate in assay transfer and assay validation as needed
  • Perform equipment qualification/maintenance
  • Prepare and maintain standards, controls, stocks, and cultures per established procedures
  • Support the maintenance and compliance of operational areas
  • Assure and apply GMP throughout operations
  • Coordinate with supplier/customers to support operational activities
  • Support internal and external audits
  • Work to meet schedules Identify and support resolution of technical problems. Resolve sample issues as needed
  • Actively participate in group and project teamwork; projects and process improvements
  • Draft protocols and reports under supervision
  • Meets scheduled performance of 95% on time (ATS)
  • Perform other duties as requested by managers to support Quality activities

 

 

Skills:

  • B.S./B.A. degree (preferably in relevant scientific discipline) or an equivalent combination of education and experience
  • Ability to write clearly and effectively.
  • Good verbal communication skills
  • Basic knowledge of scientific theories, principles and techniques used in analytical or biological test procedures
  • Ability to exercise sound judgment, reasoning and problem solving with general guidance
  • Capable of completing assigned responsibilities and keeping manager informed of status
  • Ability to work off-shift, weekends and holidays as needed
  • Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compound
  • Must be physically able to perform the following tasks: Work in a laboratory environment including biosafety cabinets.
  • Able to lift up to 25lbs.
  • Sit, stand and move within work space for extended periods

 

Education:

  • B.S./B.A. degree (preferably in relevant scientific discipline) or an equivalent combination of education and experience
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