Specialist I, Quality Assurance (Quality Systems)

Job summary

The Specialist will support the administration, maintenance, and continuous improvement of the Quality Management System at the Edmonton site. They will also partner with cross-functional stakeholders to ensure regulatory compliance, inspection readiness, and effective execution of quality processes.

Job details

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 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 Specialist I, Quality Assurance (Quality Systems), you will support the administration, maintenance, compliance, and continuous improvement of the Quality Management System (QMS) at Gilead Alberta. The position provides quality systems support for regulatory compliance activities, inspection readiness, audits, quality metrics, training programs, quality documentation, and electronic quality systems. The role partners with cross-functional stakeholders to maintain a state of inspection readiness, drive process improvements, support quality system compliance, and ensure effective execution of quality system processes. Specific Job Responsibilities: Quality Systems Administration Support administration and maintenance of Quality Management System processes. Assist with monitoring quality system effectiveness and identifying opportunities for improvement. Participate in quality system improvement initiatives and compliance projects. Support Quality Management Review activities and preparation of quality system reports. Inspection Readiness and Regulatory Compliance Support inspection readiness activities to maintain ongoing regulatory compliance. Assist in preparation for Health Canada, FDA, customer, and internal inspections. Support maintenance of site licence-related records and documentation. Quality Metrics Collect, compile, trend, and report quality metrics. Assist with preparation of management review metrics. Deviation, CAPA and Change Control Systems Support administration of deviation, CAPA, and change control processes. Assist users with quality system requirements and record management.Documentation Management Author, revise, and maintain SOPs, work instructions, forms, and supporting quality documents. Training Systems Support administration of site training programs and electronic learning systems. Assist with curriculum management, training assignments, and compliance monitoring. Support implementation and continuous improvement of training processes and systems. Electronic Quality Systems Support Provide support for quality systems applications Assist with system testing, reporting, user support, and process improvements. Support implementation of new quality and training system enhancements. Normally receives general instruction on routine work, detailed instructions on new assignments. Knowledge: Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs). Demonstrates good verbal, written, and interpersonal communication skills. Demonstrates working knowledge in Microsoft Office applications. Specific Education & Experience Requirements: 0+ years of relevant experience in a regulated field and a MS OR 2+ years of relevant experience in a regulated field and a BS OR 4+ years of relevant experience and an AA degree. Preferred: Prior experience in pharmaceutical industry is beneficial. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

What you’ll do

The Specialist will support the administration, maintenance, and continuous improvement of the Quality Management System at the Edmonton site. They will also partner with cross-functional stakeholders to ensure regulatory compliance, inspection readiness, and effective execution of quality processes.

Requirements

Candidates must have a minimum of an Associate degree with 4+ years of experience, a Bachelor's degree with 2+ years of experience, or a Master's degree with 0+ years of experience in a regulated field. A working knowledge of Good Manufacturing Practices (GMP) and Microsoft Office applications is required.

Listed skills

• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Microsoft Office · Preferred
• Process Improvement · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Assurance
• Quality Management System
• Regulatory Compliance
• Inspection Readiness
• Quality Metrics
• Deviation Management
• CAPA
• Change Control
• Documentation Management
• SOP Development
• Training Program Administration
• GMP
• Microsoft Office
• Data Trending
• Process Improvement
• Current Good Manufacturing Practices (cGMPS)
• Quality Monitoring
• Change Control Systems
• Change Control Process
• Quality Management Systems
• Auditing
• Management
• Cancer
• Corrective And Preventive Action (CAPA)
• Continuous Improvement Process
• System Administration
• Hepatitis
• Interpersonal Communications
• Management Training And Development
• Pharmaceuticals
• Quality Management
• System Testing

Job areas

• Healthcare
• Science & Research
• Manufacturing
• Administrative
• QA/QC Specialist
• Quality Assurance Specialist
• Product Graders and Testers (except Foods and Beverages)
• Inspectors, Testers, Sorters, Samplers, and Weighers

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