Senior Document Control Specialist

the Client • San Diego, CA

4d • Onsite

About The Position

The Senior Document Control Specialist is a contract role within the Infectious Disease Developed Markets (IDDM) Business Unit in Towne Centre, San Diego, California. The position executes and maintains a compliant Document Control Management System, trends quality metrics, and performs other quality-related activities in support of the Quality Management System. The role serves as the facility’s Change Order Coordinator and supports document control, training, audits, and continuous improvement.

Requirements

• Bachelor’s degree and/or an equivalent combination of education and experience.
• At least 2 years of experience in Quality Assurance or Document Control in a laboratory, medical device, or similarly regulated industry.
• Working knowledge of 21 CFR 820 and the ISO 13485:2016 standard.
• Experience processing changes using an electronic documentation system.
• Experience with technical writing, formatting, and data trending.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint, electronic document control tools, and Visio.
• Ability to understand QMS procedures and recognize deviations from approved documented procedures.
• Self-starting and detail-oriented, with the ability to focus on the task at hand.
• Ability to work independently with multiple departments to resolve Document Control issues.
• Ability to work effectively in a fast-paced, team-oriented environment.
• Well-developed written and verbal English communication skills.
• Applicants must be authorized to work for any employer in the United States; visa sponsorship or transfer is not available.
• Local candidates only; the candidate must be from the geographical area because the manager cannot wait for relocation.

Nice To Haves

• Experience with the Agile Document Management System.

Responsibilities

• Serve as the facility’s Change Order Coordinator.
• Facilitate Document Change Orders and Deviations, including formatting, coordinating review and approval, tracking and routing controlled documents, and releasing documents on time.
• Ensure new or revised documents are appropriate, justified, accurate, complete, compliant with Good Documentation Practices, and approved by the required functional areas.
• Issue document numbers, lab notebook numbers, and part numbers.
• Assist with drafting, formatting, editing, and rewriting SOPs in support of organizational quality systems.
• Ensure Document Owners complete periodic document reviews on time.
• Manage document archiving, obsolescence, and storage.
• Provide Document Control training to new and existing employees.
• Support the development of QA-related training materials.
• Assist with training assignments and collection of training metrics in Metro.
• Trend Document Control metrics for Management Review.
• Respond promptly to questions and issues from Document Owners and Approvers.
• Assist with internal and external audits.
• Support continuous improvement of the Quality Management System, with a focus on document control and change order processes.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k) retirement fund

What This Job Offers

• Career Level: Senior