Zymeworks

Quality Assurance Specialist, GxP Training

Quality - Seattle, Washington

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities, and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company.

This position will report to the Manager, Quality Systems and will be based in Seattle, WA.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

Training

• Administers and maintains the GxP training program using the ComplianceWire LMS Training platform.
• Works directly with stakeholders to ensure GxP role-based curricula are created, implemented, and accurately documented in a timely manner.
• Works with IT to ensure training requirements for electronic system access Is administered and maintained.
• Drives the periodic assessment of employee training files and coordinates annual GxP training in partnership.
• Compiles, contextualizes, evaluates, and presents GxP training data and metrics for metrics review meetings.

Quality Systems

• Supports the maintenance and improvement of Quality Systems processes and the delivery of Quality Systems projects.
• Identifies and recommends opportunities for improvement to the Quality Systems Manager with regards to the training system, document control, CAPA/Deviation program, etc.
• Supports the Quality Systems Manager in the planning and directing of overall Quality System activities Provides guidance and mentorship to quality systems associates and other department members.
• Understands and supports the Veeva "Quality Docs" document control system (as it links to ComplianceWire LMS) and the quality systems associated with GxP operations.
• Participates In change control workflows and supports the GxP Change Review Board process.
• Participates in and may drive completion of investigations and corrective action implementation for identified quality systems issues including internal/external audits actions.
• Works directly with various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner.

Qualifications and Education

• Bachelor’s degree in Biology, Chemistry or another relevant discipline, and a minimum of 5 years’ experience in a GxP-regulated work environment (Quality Assurance, Quality Control, Biologics/Pharmaceutical Manufacturing, etc.) including at least 1 year in a GxP training role.
• An equivalent combination of education and experience may be considered.

Skills and Abilities:

• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
• Ability to establish and maintain effective working relationships.
• Ability to assess priorities and successfully manage workload to timelines.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to analyze medium to complex data and glean basic information from the data.
• Strong knowledge of GMP regulations and Quality Systems.
• Knowledge of process mapping and other improvement methods.
• Working knowledge of the use of Microsoft Office suite.
• Strong organizational and communication skills.
• Demonstrated ability to interact with teams across the company to ensure the compliance of the GMP operations.
• Understanding of basic scientific/technical concepts.
• Demonstrated ability to meet deadlines and manage priorities in a dynamic environment, while providing excellent service to internal customers.
• Embody and champion Zymeworks’ values: Innovate. Act with Integrity. Collaborate. Care.
• Previous experience with electronic quality systems such as document control, training, and change control (preferred).

How to Apply

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 04/23/2022