Document Control Specialist

Mechanix Wear • Santa Clarita, CA

30d • $29 - $35

About The Position

The Document Control Specialist ensures the integrity, availability, and compliance of all controlled documents across our manufacturing operations. This role supports the Quality Management System (QMS) and regulatory requirements by maintaining accurate documentation, enabling efficient change control, and helping prepare for audits. The ideal candidate has strong attention to detail, experience with electronic document management systems (EDMS), and a working knowledge of quality and regulatory standards relevant to PPE and consumer products.

Requirements

• Bachelor’s degree in Quality Assurance, Engineering, Manufacturing, or a related field; or equivalent combination of education and experience.
• 2–5+ years in document control, quality systems, or regulatory documentation in a manufacturing environment (PPE or consumer goods preferred).
• Proficiency with an electronic document management system (EDMS) and standard office software (MS Office 365).
• Familiarity with quality management principles and requirements (ISO 9001; ISO 13485 and FDA QSR knowledge a plus).
• Understanding of GMP/GLP concepts and regulatory compliance relevant to PPE/manufacturing.
• Ability to read and interpret technical drawings, specifications, and SOPs.
• Exceptional attention to detail and organizational skills.
• Strong written and verbal communication.
• Ability to manage multiple tasks and meet deadlines; collaborative mindset.

Nice To Haves

• Certifications: ASQ Certified Quality Auditor (CQA) or similar; Document Control Specialist certification.
• Experience with supplier documentation, validation/verification records, and audit preparation.
• Experience in a PPE, medical device, or consumer goods manufacturing environment.

Responsibilities

• Manage the end-to-end document control process for all controlled documents (SOPs, work instructions, forms, specifications, validation/verification records, quality manuals, batch records, training records).
• Maintain and enforce version control, routing, approvals, metadata, and secure access within the EDMS (e.g., Master Control, Arena, or similar).
• Coordinate and track document changes through the change control process; ensure timely updates, archival, and distribution to affected stakeholders.
• Support internal and external audits by ensuring documents are current, traceable, and readily accessible; assist with evidence requests and corrective actions (CAPA) related to documentation.
• Ensure alignment of documents with applicable standards and regulatory requirements (ISO 9001, ISO 13485 if applicable, FDA QSR 21 CFR Part 820, REACH, RoHS, etc.).
• Maintain supplier-related documentation (quality agreements, certificates of conformity, material specifications) and ensure documentation reflects current supplier status.
• Manage training records and verify that employees have access to and completion of required procedures and work instructions.
• Assist with validation/verification documentation for processes and equipment; maintain document ownership and approval trails.
• Implement and monitor records retention schedules; oversee proper destruction of obsolete documents.
• Support label, packaging, and compliance documentation for PPE products as needed.
• Promote data integrity, accuracy, and security; enforce user access controls and audit trails.
• Collaborate with QA, Regulatory, Manufacturing, and Supply Chain to resolve document-related issues and drive process improvements.
• Work closely with R&D, Product, Sourcing, Quality, Marketing and Manufacturing teams to collect and align product data, Testing, and Compliance.
• Support special projects during various product developments.

Benefits

• medical
• dental
• vision
• 401(k) plan
• life insurance coverage
• wellness benefits
• education reimbursement program
• Vacation time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level