Quality Assurance, Change Controls, Pharmaceutical
Irvine, CA
Contracted to Full Time
Manager/Supervisor
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
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