Senior Document Control Specialist

generis Tek • San Diego, CA

4d • Onsite

About The Position

This contract opportunity is with the Infectious Disease Developed Markets (IDDM) business unit at the client’s Towne Centre San Diego location. The Senior Document Control Specialist will execute and maintain a compliant Document Control Management System, trend quality metrics, and perform other quality-related activities in support of the Quality Management System. The role is onsite in San Diego, California, and is scheduled for three months, Monday through Friday, 9:00 AM to 5:30 PM. The stated pay rate is $32.00 per hour on W-2.

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.
• Agile Document Management System experience.
• Proficiency with MS Office, including Word, Excel, and PowerPoint, as well as electronic document control tools and Visio.
• Ability to understand QMS procedures and recognize deviations from approved documented procedures.
• Self-starting, detail-oriented, and able 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 English written and verbal communication skills.

Responsibilities

• Perform the facility’s Change Order Coordinator role.
• Facilitate Document Change Orders and Deviations, including formatting, coordinating reviews and approvals, tracking and routing controlled documents, and timely document release.
• Ensure new and revised documents are appropriate, justified, accurate, complete, compliant with Good Documentation Practices, and approved by required functional areas under established procedures.
• 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 in a timely manner.
• Manage document archiving, obsolescence, and storage.
• Provide Document Control training to new and existing employees.
• Support 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 Document Owner and approver queries and issues.
• Assist with internal and external audits.
• Support continuous improvement of the Quality Management System, with a focus on document control and change order processes.

What This Job Offers

• Career Level: Senior