Senior Document Control Specialist

Techlink Systems Inc.; San Diego (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Techlink Systems Inc. in San Diego, CA seeks a Senior Document Control Specialist for a contract role concluding 20 October 2026. Onsite, 40 hours/week, 9:00am–5:30pm. You will manage change orders, document control processes, and write/format SOPs to support QA systems.

Ideal candidates have a Bachelor's degree and 2+ years in regulated QA or document control, with knowledge of 21CFR820 and ISO 13485:2016. Strong MS Office and training skills are a plus.

Qualifications

• Bachelor's degree or equivalent required.
• 2+ years in QA or document control in regulated industry.
• Familiarity with 21CFR820 and ISO 13485:2016.
• Experience with electronic doc management systems.
• Strong technical writing and data trending skills.

Responsibilities

• Coordinate change orders and deviations; track and release documents.
• Ensure documents are accurate, justified, and compliant with procedures.
• Issue document, lab notebook, and part numbers.
• Draft, format, and edit SOPs for QA systems.
• Manage document reviews, archiving, obsolescence, storage.
• Provide document control training and QA training materials.

Skills

Microsoft Office

QMS understanding

Independent work

Team collaboration

Education

Bachelor's Degree or equivalent

Tools

Electronic document control system

Visio

Microsoft Office (Word/Excel/PowerPoint)

Job description

Senior Document Control Specialist

Location: 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