QA Specialist I

1 day ago

Edmonton, Canada Gilead Sciences, Inc. Full time

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

- High School diploma with 5+ years of relevant experience in a GMP environment, or Associates degree in chemistry, or a related field with 4+ years of relevant experience in a GMP environment, or Bachelors degree in chemistry, or a related field with 2+ years of relevant experience in a GMP environment, or Masters degree in chemistry, or a related field.
- Must be able to think critically and creatively, solve routine problems, work independently, and have strong organizational and planning skills.
- Must have excellent interpersonal, verbal, and written communication skills.
- Knowledge of GMP regulations, including ICH Q7 and GUI-0104 is preferred.
- Experience with inventory management computerized systems is preferred.

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Job Requisition ID R0045146

Full Time/Part Time Full-Time

Job Level Associate

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