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Form of work Job Description:
Pay Range 43.95hr - 45.95hr
Responsibilities:
Pay Range 43.95hr - 45.95hr
Responsibilities:
- Managing an electronic document system for the Bothell site which includes reviewing and approving document change requests, troubleshooting, 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.
- 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.
- ssist with cross-training of Document Control personnel and customers to ensure adherence to 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 if required.
- ssist with document retrieval /organization support during regulatory inspections.
- Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
- Minimum of 1 year of relevant document control management experience in a cGMP/FDA-regulated environment.
- Strong communication and customer service skills.
- Some technical writing skill set and being able to critically review documents while effectively inputting and expressing Quality principles.
- 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.
- ble to prioritize, manage time well, multi-task, and troubleshoot effectively.
- bility to work effectively and collaboratively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.
- Possesses project management skills.
- Experience interacting with FDA or other regulatory agencies is strongly preferred.
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc).
- Must complete tasks independently, notify manager of decisions outside of established processes, and have the ability to build an internal network.
- 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.
