Sr. QA Specialist - QC SupportUnited States - California - La VerneGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.
With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world.
Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Job DescriptionWe are seeking a highly motivated individual to join us as a Sr. QA Specialist for the Gilead La Verne Quality Assurance Department.
This role involves collaborating with cross-functional teams to ensure the QC testing comply with Quality and Regulatory requirements through its lifecycle.Responsibilities:Monitor industry practices and relevant regulatory and pharmacopoeia guidance for biological product testing to ensure compliance.
Lead gap assessments and mitigation plans as needed.Review and approve biological test methods and method validation/transfer reports.Review and approve lab investigations associated with release testing and method validation/transfer at the site or contract testing laboratories.Support biological product sample management (e.g., reserve, reference standards) and cell bank management.Liaise with cross-site QAs and Analytical Leads to resolve issues and improve practices and workflow efficiency.Lead the QA review of analytical data, including data audit trails; Manage and train QA specialists on activities related to QA support of analytical activities.Review and approve biological analytical instrument qualification protocols and reports as needed.Manage cross-functional teams, including organizing and prioritizing daily tasks.Participate in authoring, review, and approval of new or revised standard operating procedures, specifications, forms, test methods and other controlled documents to ensure high quality documents and compliance with current Good Manufacturing Practices (GMPs).Support internal and external audits, site inspection readiness activities, and continuous improvement initiatives.Participate in review and approval of Deviations, CAPAs, and Change Management records as required.Participate in the QA oversight of stability program and lifecycle management of test method initiatives.Communicate with cross-site teams to align practices and drive continuous improvement.Deliver biological GMP training to the QA/QC group.Qualifications:Bachelors Degree and 6+ years of experience required ORMasters Degree and 4+ years of experience required ORExperience with biological method development, verification, validation and transfer required.Familiar with biological product (excipient, drug substance and/or drug product) specification development desired.Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements, ICH Q2/Q14/M10, and USP .Experience across broad areas of Quality Assurance and/or Quality Control Systems.Demonstrated ability to develop, coach and mentor employees.Excellent interpersonal, verbal, and written communication skills.Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is preferred.
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