Quality Assurance, Change Controls, Pharmaceutical Job at GForce Life Sciences, Irvine, CA

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  • GForce Life Sciences
  • Irvine, CA

Job Description

Sr Manager/Associate Director, Quality Assurance, Change Controls, Pharmaceutical

Summary

Our client, a biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with significant unmet needs, particularly in eye care, has engaged with GForce to identify a Quality Assurance consultant.

This person will be responsible for the review and processing of manufacturing Deviations and laboratory OOS and review of manufacturing and laboratory-related Change Controls within the established QMS system. This role will also be responsible for the approval of Certificates of Analysis, manufacturing batch record review, and product disposition.

Duties / Expectations of Role

  • Support QA activities for early-phase (preclinical through clinical phase I/II) clinical development programs
  • Ensure compliance with GMP in addition to internal policies and procedures
  • Provide strategic QA input to cross functional teams, including Clinical, Regulatory Affairs, Analytical Development and CMC
  • Serve as QA representative on development project teams and advise on risk mitigation strategies
  • Contribute to the authoring and review of SOPs, protocols, reports and specifications
  • Process and approve change controls, OOS and deviations within the QMS system
  • Review and approve CMO’s master batch records, analytical documents and validation protocols
  • Review executed batch records and disposition batches per internal policies and procedures
  • Participate in CMO and internal operations meetings

Mandatory Requirements

  • Bachelor’s or advanced degree in life science or a related field
  • 7-10 years of experience in Quality Assurance within the pharmaceutical / Biotechnology industry
  • Experience in early-phase clinical development and a sound understanding of the drug development life cycle
  • Strong knowledge of deviation and change control systems.
  • Laboratory background with method methods
  • Experience with investigations using root cause analysis, CAPA and CAPA effectiveness
  • ASQ Certification Preferred
  • Sterile products experience preferred

Term & Start

  • 6-month contract with intent to convert to FTE
  • Hybrid 3 days a week in Orange County, CA

Job Tags

Contract work, 3 days per week,

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