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QA Specialist - II
Ref No.: 18-08749
Location: Foster City, California
Job Title: QA Specialist II
Location: Foster City, CA
Duration: 6 Months

Job Description:
  • A temporary resource is sought to provide support to the Quality Operations Group at the Client Sciences Foster City, CA Site. The candidate's main duties will be to support Inspection Readiness, Quality Risk Management and general QA validation oversight of qualifying Facility, Utilities, and Process Equipment.
  • Must have prior experience in the pharmaceutical /biotech industry and a working knowledge of 21cFR210/21CFR211/21CFRPart11. Additional proficiencies in the use of Word, Excel, Powerpoint, Visio, Maximo, and Trackwise software are desirable. Essential duties include supporting the inspection readiness in the preparation and planning for regulatory inspections, which may include training and logistical support. In addition, the candidate may be required to provide first-line QA review of Equipment, Facilities and Utilities IQ, OQ and PQ documents.
Knowledge, Experience and Skills:
  • Must have strong knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks.
  • Experience in Quality Risk Management and risk-based qualification tools (PHA, FMEA).
  • Experience with implementation/improvement of quality systems.
  • Experience providing QA oversight of facility changes, equipment qualification and lab system validation.
  • Excellent communication skills (both oral and written) including the ability to effectively communicate across organizational levels and functions.
  • Facilitate open communication and sharing of knowledge.
  • Specific Education and Experience: Typically requires a BA or BS degree and minimum 5 years of relevant experience in related field or a MA or MBA degree and minimum 4 years of relevant experience.
Academic Level:
  • Bachelors