Quality Assurance Document Control Labeling Specialist

Job Post Index 24181E-Sy##
Location Bothell, WA
Description: Description
  • Supports the cGMP Document Control operations for the site, including the coordination, issuance, reconciliation, and management of production labels and records.
  • Issuing production labels, batch records, and other controlled documents to support manufacturing operations
  • Coordination of work activities to support manufacturing
  • Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility
  • Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests
  • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures
  • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site
  • Support internal and external audits and regulatory inspections.
  • This may require data gathering, interviewing or escorting auditors during the audit.
  • Assist with document retrieval /organization support during regulatory inspections
  • Managing an electronic document system for the site which includes reviewing and approving document change requests, troubleshooting and and releasing documents to an effective state
  • May write and revise document control procedures including participating in the development and roll-out of document control tools
  • Perform Document Control metric reporting and analysis for the local site data.
  • Develop and improve label issuance processes to drive operational efficiency
  • This may require the use of relational databases and reporting tools to collate and analyze quality data
  • Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders
  • Supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
Skills: Qualifications
  • Bachelor’s degree or equivalent
  • Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment
  • Some document management experience
  • Strong attention to detail and an analytical mindset.
  • Crystal reports experience preferred
  • Strong communication and customer service skills.
  • Strong 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 improvement
  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively
  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
  • Possess project management skills.
  • Experience interacting with FDA or other regulatory agencies strongly preferred
  • Strong knowledge of cGMPs and domestic regulatory requirements
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
  • Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network

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