Sr. Quality Assurance Specialist
About The Position
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Quality Assurance Specialist at Gilead you will have the following responsibilities: Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products. Responsible for final release of manufactured products. Participates in introduction of new clinical/commercial products (e.g., small molecules and biologics) to the site. Participates in risk assessments. Participates in author, review, and approval of changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). Participates in site inspection readiness activities. Participates in internal and external audits as needed. Participates in continuous improvement initiatives. Supports generation, and review of metrics and trending data. Partner with internal partners to ensure resolution of quality issues. Participates in review/approval of Deviations, CAPAs, and Change Management records as required. Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgement is required in resolving problems and making scientific routine recommendations. Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
Requirements
- Bachelors Degree and 6+ years of experience required OR Masters Degree and 4+ years of experience required OR PhD or PharmD with 0+ years of experience
- Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements.
- Experience across broad areas of Quality Assurance and/or Quality Systems.
- Experience with interacting with regulatory agencies.
- Excellent interpersonal, verbal, and written communication skills.
- Knowledge of Risk Management tools (e.g., HACCP and FMEA)
Nice To Haves
- Advanced degree (Masters or PhD/PharmD) is preferred
- Experience with batch record review and release of clinical and/or commercial product preferred
- Experience with medical devices preferred
- Experience with biological products
Responsibilities
- Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products.
- Responsible for final release of manufactured products.
- Participates in introduction of new clinical/commercial products (e.g., small molecules and biologics) to the site.
- Participates in risk assessments.
- Participates in author, review, and approval of changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Participates in site inspection readiness activities.
- Participates in internal and external audits as needed.
- Participates in continuous improvement initiatives.
- Supports generation, and review of metrics and trending data.
- Partner with internal partners to ensure resolution of quality issues.
- Participates in review/approval of Deviations, CAPAs, and Change Management records as required.
- Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors.
- Considerable judgement is required in resolving problems and making scientific routine recommendations.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
