Senior Document Control Specialist

Job Title: Senior Document Control Specialist
Location (On-site, Remote, or Hybrid?): San Diego, CA (onsite)
Contract Duration: Contract until 10/20/2026
Working hours: 9:00am - 5:30pm
Total hours: 40

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.
• Trend Document Control Metrics for Management Review.
• 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.
• Agile Document Management System experience preferred.

COMPETENCIES:

• Proficient with Microsoft Office, including Word, Excel, PowerPoint, electronic document control tools and Visio.
• Ability to understand QMS procedures and ability to recognize deviations from approved documented procedures
• Self-starting, detail oriented, and ability to focus on task at hand
• Ability to work independently with multiple departments to resolve Document Control issues
• Must be able to work effectively in a fast paced, team-oriented environment
• Well-developed English written and verbal communication skills