QA Associate Specialist Document ControlLocation: Bothell, WAApart of the JUMP Project InitiativeTop Skills:EDMS Experience. Preferably 3-5 years. Systems include VIVA, Master Control, & Documentum etc.Ability to manage competing prioritiesTeamwork and collaborationPurpose And Scope Of PositionThe Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Bothell site, including the document change control process as well as review and approval of documents within the document management system.Required CompetenciesKnowledge, Skills, and Abilities:Education: Bachelor's degree or equivalentExperience: Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environmentStrong communication and customer service skills. Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principlesStrong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvementAbility to prioritize, manage time well, multi-task, and troubleshoot effectivelyAbility to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverablesPossess project management skills.
Experience interacting with FDA or other regulatory agencies strongly preferredStrong knowledge of cGMPs and domestic regulatory requirementsKnowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal networkDuties And ResponsibilitiesPrimary responsibilities include:Managing an electronic document system for the Bothell site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective stateMay write and revise document control procedures including participating in the development and roll-out of document control toolsFollow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requestsAssist with cross-training of Document Control personnel and customers to ensure adherence with proceduresExecute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the siteSupport internal and external audits and regulatory inspections if requiredAssist with document retrieval /organization support during regulatory inspectionsProvide communication as to the status of Quality Systems deliverables to customers, management, and stakeholdersWorking Conditions (US Only)Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts. Weekend and off-shift support may be required.