QA Specialist

Quality Seattle, Washington


Description

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.  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.

 
About the Position

Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company. The Quality Deviation and Change Control Specialist will support the tracking, trending and monitoring function for Deviations and Change Controls within the Quality System. 

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

Key Responsibilities

  • Administers and maintains the Deviation and Change Control programs using the electronic Veeva Quality Management System (QMS).
  • Works directly with stakeholders to ensure Deviation and Change Control tasks are closed accurately and in a timely manner.
  • Leads periodic cross-functional meetings on Deviations and Change Controls to discuss and track open issues and maintain accountability. 
  • Proactively examines/reviews the QMS and related processes to identify/assess areas for review, improvement, change, or elimination with a focus to simplify and standardize processes. May lead and drive improvements as required.
  • Utilizes quality tools to compile, track, trend, and communicate 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
  • 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 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. 
  • 5+ years’ experience in a GMP-regulated work environment (Quality Assurance, Quality Control, Biologics/Pharmaceutical Manufacturing, etc.).  


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 use of 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 for document control, training, deviations and change control (preferred). 


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. 

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