Specialist I, Quality Assurance (Quality Systems)

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:

• 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.

• 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.

• Collect, compile, trend, and report quality metrics.
• Assist with preparation of management review metrics.

• 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.

• 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.

• 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.