Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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. The GxP Training Coordinator will provide training support to the the quality team as well as support broader quality systems work. This position will be based in Seattle and will report to the Quality Systems Manager.
- Adminsiters and maintains the GxP training program using the Veeva QMS to outline all GxP role-based training matrices.
- Works directly with stakeholders to ensure GxP role-based curricula are created, implemented and accurately documented in a timely manner.
- Drives the periodic assessment of employee training files and coordinates annual GxP training in partnership with the LMS admin.
- Compiles, contextualizes, evaluates, and presents GxP training data and metrics for metrics review meetings.
- Supports the maintenance and improvement of Quality Systems processes and the delivery of Quality Systems projects.
- Works directly with various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner.
- Identifies and recommends opportunities for improvement to the Quality Systems Manager with regards to the training system, document control, CAPA/Deviation program, external and internal audit management, 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 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.
Qualifications and Experience
- Bachelor’s degree in Biology, Chemistry or other relevant discipline, and a minimum of 5 years’ experience in a GMP-regulated work environment (Quality Assurance, Quality Control, Biologics/Pharmaceutical Manufacturing, etc.) inclusing at least 1 yyear 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 define problems, collect data, establish facts, and draw valid conclusions.
- Embody and champion Zymeworks’ values: Innovate. Act with Integrity. Collaborate. Care.
- Ability to assess priorities and successfully manage workload to timelines.
- Ability to analyze moderate 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 use of Microsoft Office suite.
- Strong organizational and communication skills.
- Demonstrated ability to interact with team across the companyto ensure the compliance of the GMP operations.
- Understanding of basic scientific/technical concepts.
- Demonstated ability to meet deadlines and manage priorities in a dyamnic environment, while providing excellent service to internal customers.
- Previous experience with electronic quality systems such as for document control, training, and change control (preferred).
Why Work for Us?
At Zymeworks, we stand for innovation, integrity, collaboration and care.
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at https://zymeworks.bamboohr.com/jobs/.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.com/jobs/view.php?id=361. Due to the high volume of applicants, only those selected for interviews will be contacted.
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.Apply Now