1 senior document control specialist jbp2026 jobs found
Job Description
Job Description\nCompany Description
Senior Document Control Specialist
Location: San Diego, CA (Onsite)
Payrate: $35/Hr
Schedule: Monday–Friday, 9:00 AM–5:30 PM
Hours: 40 hours/week
Job Description
We are seeking a Senior Document Control Specialist to support document control and quality processes within a regulated environment. This role will coordinate document changes, manage controlled documents, support SOP development, and ensure compliance with quality and regulatory requirements.
Responsibilities
- Serve as the Change Order Coordinator for the facility.
- Coordinate Document Change Orders (DCOs) and deviations from start to finish.
- Format, edit, track, route, and release controlled documents.
- Coordinate document review and approval with the appropriate departments.
- Ensure documents are accurate, complete, properly formatted, and compliant with Good Documentation Practices.
- Assign document numbers, lab notebook numbers, and part numbers.
- Assist with writing, editing, and updating SOPs and quality documents.
- Manage periodic document reviews, archiving, obsolete documents, and document storage.
- Provide Document Control training to new and existing employees.
- Support the development of QA-related training materials.
- Assist with training assignments and tracking training metrics.
- Monitor and trend Document Control metrics for management.
- Respond to questions and issues from Document Owners and Approvers.
- Support internal and external audits.
- Help improve the organization's Quality Management System (QMS), with a focus on Document Control and change management.
Qualifications
- Bachelor's degree or equivalent combination of education and experience.
- 2+ years of experience in Document Control or Quality Assurance.
- Experience working in a regulated industry, such as medical devices, laboratory, biotechnology, pharmaceutical, or similar.
- Working knowledge of 21 C0FR 82 and ISO 13485:2016.
- Experience processing document changes using an electronic document management system.
- Experience with technical writing, document formatting, editing, and data trending.
- Agile Document Management System experience is preferred.
- Proficiency with Microsoft Office, especially Word, Excel, and PowerPoint.
- Experience with electronic document control tools and Visio is a plus.
- Strong attention to detail and organizational skills.
- Ability to work independently and collaborate with multiple departments.
- Strong written and verbal communication skills.
- Ability to work effectively in a fast-paced, team-oriented environment.
Ideal Candidate
The ideal candidate has 2+ years of Document Control or QA experience in a regulated environment, preferably medical device or laboratory. They should be comfortable coordinating document changes, working with SOPs and QMS procedures, and using electronic document management systems.
If you have experience with Document Control, Change Orders, SOPs, ISO 13485, or 21 CFR 820, we encourage you to apply!
TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.
We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.
About Techlink Systems