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QA Specialist I
3 weeks ago
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**:
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.
For Current Gilead Employees and Contractors:
