QA Specialist I

QA Specialist I

Canada - Alberta - Edmonton Process / Product Development & Operations Regular

We are seeking a highly motivated individual to join us as a QA Specialist I for the Gilead Alberta Quality Assurance department. This role involves collaborating with multi-disciplinary cross-functional teams to support materials management oversight at Gilead Alberta.

Responsibilities

• Performs a variety of activities to ensure compliance with applicable Good Manufacturing Practices (GMPs) requirements.
• Author and manage qualification reports, quality agreements and supplier assessments as part of the supplier qualification program.
• Coordinate investigation of sample shipment excursions and product assessments. May coordinate / assist with the completion of related corrective and preventive actions (CAPAs).
• Coordinate activities associated with disposition of material status in the material management system.
• Manage vendor complaints for purchased materials in collaboration with the Supply Chain team.
• Review shipping related documentation and oversee shipment of GMP materials.
• Support internal and external audits, site inspection readiness activities, and continuous improvement initiatives.
• Author changes to procedures, work instructions, or other controlled documents relating to material management.
• Participate in Quality Risk Management activities to support site operations.
• Work with diverse and cross-functional teams to support site activities, and independently manage responsibilities, including organizing and prioritizing daily tasks.
• Utilize critical thinking abilities and risk-based judgment to solve routine problems and recommend actions.
• Communicate with cross-site teams to align practices and drive continuous improvement.

Qualifications

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Job Requisition ID R0045146

Full Time / Part Time Full-Time

Job Level Associate

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