QA Specialist II - CA in Foster City, CA at Apex Life Sciences

Date Posted: 8/6/2018

Job Snapshot

Job Description


Description:

  • A temporary resource is sought to provide support to the Quality Operations Group.
  • 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: 
    • Minimum of a Bachelors

For immediate consideration, please send resumes to khurlbut@apexlifesciences.com

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.