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Form of workJob Description
Our Medical Device client is looking for an outstanding Document Control Specialist who will effectively execute and maintain compliant Document Control Management System. In addition, this role will also trend quality metrics and perform other quality related activities to support the Quality Management System.
Title: Document Control Specialist
Pay: $32/hr-$35/hr
Location: San Diego, CA
RESPONSIBILITIES:
· Perform the role of Change Order Coordinator for the facility.
· Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release of documents in a timely manner.
· Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
· Issue document numbers, lab notebooks numbers and part numbers.
· Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
· Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
· Perform Document Control training for new and existing employees.
· Support development of QA-related training materials.
· Assist with training assignment and collection of training metrics in Metro.
· Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
· Assist with internal and external audits.
· Support the continuous improvement to the Quality Management System, with a specialty focus on Document Control and change order processes.
BASIC QUALIFICATIONS | EDUCATION:
· Bachelor's Degree and/or an equivalent combination of education and experience.
· 2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
· Working Knowledge of 21CFR820, ISO 13485:2016 standard.
· Experience processing changes using an electronic documentation system
· Experience with technical writing, formatting and trending of data.
· Electronic Document Management System experience required.
· Agile experience preferred.
Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.
