Document Control Specialist
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. This position will be based in Seattle and will report to the Director, Quality Assurance.
- Manages the Electronic Document Management System (EDMS) with high level of expertise, including support of routine users and processes, as well as IT interface to support system updates and expansion.
- Manages the EDMS document life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.
- Trains personnel on the EDMS system with customer-service orientation to optimize workflow and tracking as well as resolve workflow issues
- Establishes and maintains procedures, policies and systems needed to meet the requirements of document control in a biotechnology company.
- Maintains hard copy GxP documentation files, including archival, retention and/or destruction as per quality procedures.
- Manages incoming external documentation from Contract Research Organizations and Contract Manufacturing Organizations including master batch files, executed batch files, raw data, method validation protocols and reports, stability and release testing data, study protocols and reports, specifications, and other controlled documents, as required.
- Maintains GxP employee training records.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience
Associate degree or equivalent required, bachelor degree preferred, and a minimum of 2 years’ hands-on GxP Compliance experience related to document management.
Skills and Abilities
- Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional team. Ability to establish and maintain effective working relationships
- Good organizational skills and the ability to work effectively in a high paced, fast changing environment. Results-oriented with the ability to prioritize
- Experience managing electronic document management systems
- Experience with Veeva Vault, a cloud-based content management system preferred
- Performance driven with an understanding of how to work collaboratively with cross-functional teams
- Positive, enthusiastic and customer service oriented
- Excellent editing, grammar and proofreading skills
- Experience with Computer System Validation, preferred
- Proficiency with MS Office