Senior Document Control Specialist

Senior Document Control Specialist

Location: San Diego, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 3 months
• Pay Rate: $33.66 / Hour (USD)
• Shift / Schedule: Monday – Friday, 9:00 AM – 5:30 PM
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

ThisDocument Control Specialist opportunity is available within the Infectious Disease Developed Markets (IDDM) Business Unit, at the location in Towne Centre San Diego, CA. The role will effectively execute and maintain a 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.

Key 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 releasing documents in a timely manner.
• Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meet Good Documentation Practices, and approved by the required functional areas according to established procedures.
• Issue document numbers, lab notebook 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 promptly.
• Assist with internal and external audits.
• Support the continuous improvement of the Quality Management System, with a specialty focus on document control and change order processes.

Required Skills

• 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 able to focus on the 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.

Education Requirements

• Bachelor's Degree and/or an equivalent combination of education and experience.

Required 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 and ISO 13485:2016 standard.
• Experience processing changes using an electronic documentation system.
• Experience with technical writing, formatting, and trending of data.

Nice-to-Have Experience

• Agile Document Management System experience preferred.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Local candidates only — candidate must be from the geographical area, as the manager cannot wait for relocation.
• Interview process: Phone interview followed by video interview or face-to-face interview.
• Candidate will start ASAP after selection and all screenings are complete.

About the Client

This client is a leadinghealthcare innovator dedicated to improving lives worldwide, with operations spanning medical devices, diagnostics, and nutrition products across more than 160 countries. The organization's portfolio includes cardiovascular care, diabetes management, diagnostic testing, nutritional science, and neuromodulation, with recognized brands that millions of patients rely on every day. With a workforce that includes biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals, this global organization employs tens of thousands across four major business segments and is a certified Great Place to Work, with 80 percent of employees reporting it as a great workplace — well above the national average.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-16875

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