Zymeworks

Quality Assurance Associate II, Quality Systems

Quality - Seattle, Washington

Description

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 Quality Assurance Associate II, Quality System will support the Quality Systems team with a focus on Document Control. This position will be based in Seattle and will report to the Quality Systems Manager.

Key Responsibilities:

• Supports the Document Control team through tracking open tasks and documents to ensure timely completion and accountability.
• Works directly with stakeholders to ensure Document Control tasks are closed accurately and in a timely manner.
• Understands and supports the Veeva "Quality Docs" document control system and the quality systems associated with GxP operations.
• Supports the Deviation and Change Control programs using the electronic Veeva Quality Management System (QMS).
• Utilizes quality tools to assist in the compilation, tracking, trending, and communicating QMS metrics in presentations, reports, and dashboards.
• Supports the maintenance and improvement of Quality Systems processes in general and the delivery of Quality Systems projects.
• Supports the Quality Systems Manager in the planning and directing of overall Quality System activities
• Participates in and may drive completion of investigations and corrective action implementation for identified quality systems issues including internal/external audits actions.
• Other duties/responsibilities as assigned

Qualifications and Experience

• Bachelor’s degree in Biology, Chemistry or other relevant discipline or equivalent work experience.
• 2+ years’ Quality Systems experience in a GMP-regulated work environment
• An equivalent combination of education and experience may be considered.
• Embody and champion Zymeworks’ values: Innovate. Act with Integrity. Collaborate. Care.
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

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 moderate to complex data and glean basic information from the data.
• Strong knowledge of GxP regulations and Quality Systems.
• Knowledge of process mapping and other improvement methods.
• Working knowledge of the Microsoft Office suite.
• Strong organizational and communication skills.
• Understanding of basic scientific/technical concepts.
• Positive, enthusiastic, and customer service oriented.
• Previous experience with electronic quality systems such as document control, training, deviations, 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=372. 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.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 01/30/2021