Quality Control Specialist
6 days ago
We are seeking a highly motivated individual to join us as a Senior Specialist, Quality Assurance for the Gilead Alberta Quality Assurance department.
About the JobThis role involves collaborating with multi-disciplinary cross-functional teams to ensure that QC testing complies with Quality and Regulatory requirements through its lifecycle.
- Review and approve analytical test methods and method validation/transfer reports.
- Review and approve lab investigations associated with release testing, equipment cleaning, and method validation/transfer at the site or at contract testing laboratories.
- Perform QA review of analytical testing data, including data audit trails.
Key Responsibilities:
- Participate in authoring, review, and approval of new or revised standard operating procedures, forms, test methods and other controlled documents to ensure compliance with current Good Manufacturing Practices (GMPs).
- Support internal and external audits, site inspection readiness activities, and continuous improvement initiatives.
- Review and approve analytical instrument qualification protocols and reports, as needed.
Requirements:
- Bachelor's degree in chemistry, or a related field, and 6+ years of relevant experience in a GMP environment.
- Or Master's degree in chemistry, or a related field, and 4+ years of relevant experience in a GMP environment.
- Or PhD in chemistry, or a related field. Experience in a GMP environment is preferred.
Desirable Skills:
- Experience with analytical method development, verification, validation and transfer are required.
- Knowledge of GMP regulations, including ICH Q7, Q9, Q10 is preferred.
- Experience across broad areas of Quality Assurance and/or Quality Control Systems is preferred.
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