QA Specialist I

3 weeks ago

Edmonton, Canada Gilead Sciences, Inc. Full time

QA Specialist ICanada - Alberta - Edmonton Process/Product Development & Operations RegularWe 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.ResponsibilitiesPerforms 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.QualificationsHigh 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.Share:Job Requisition ID R0045146Full Time/Part Time Full-TimeJob Level AssociateClick below to return to the Gilead Careers siteClick below to see a list of upcoming eventsClick below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr

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