Sr Specialist QA AFP

Location: Thousand Oaks, CA
Date Posted: 09-05-2017

Day to Day Responsibilities:
Coordinate and lead or participate in Corporate Quality Compliance audits of internal and external sites; utilize auditing experience of Drug Substance for Biotechnology cell based products and small molecules and Quality Control Laboratories. Apply knowledge of current regulatory regulations, standards and guidelines, in addition to requirements of applicable Standard Operating Procedures (SOP’s) in the conduct of these audits. Responsibilities include:
  • Pre-audit planning including scheduling, determining scope and applicable regulatory standards, and developing an audit plan
  • Conducting the audit either leading an audit team or participating as a team member in identifying compliance risks
  • Managing audit follow-up activities, including report writing, response assessment, and closure.

Preferred Qualifications
MS degree in Science with 5+ years of experience in a regulatory compliance position supporting the manufacture and testing of pharmaceutical products.
Must have experience in GMP auditing.

"This posting is for Contingent Worker, not an FTE"
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