Documents Control Specialist

Kalon Executive Search • San Diego, CA

2d • Onsite

About The Position

Our client, a San Diego based supplement manufacturer, is seeking a Document Control Specialist to manage and maintain quality documentation in support of cGMP compliance. This role partners with Quality, Production, and Regulatory to ensure all documents are accurate, current, and audit-ready. This is an in person position in San Diego, CA.

Requirements

• 3+ years document control experience in supplements, food, or pharma (supplements preferred)
• Strong knowledge of FDA 21 CFR Part 111 (MMRs, BPRs, recordkeeping)
• Experience with specification sheets and GDP/data integrity
• Detail-oriented with strong organizational and communication skills
• Proficient in Microsoft Office
• FDA inspection or GMP audit support experience (NSF, UL, etc.)
• Familiarity with CAPA and change control systems
• Experience in small-to-mid-size manufacturing environments

Nice To Haves

• QMS experience a plus

Responsibilities

• Create, revise, and archive, controlled documents (MMRs, BPRs, SOPs, specs, forms) per 21 CFR Part 111
• Maintain raw material, in-process, and finished product specifications aligned with CoAs and label claims
• Manage document change control, approvals, and version tracking
• Maintain document control logs and master index for traceability
• Support audits and FDA inspections by organizing and retrieving records
• Ensure proper issuance, review, and filing of production records
• Assist with CAPA, deviations, and change control documentation
• Train staff on document control and GDP

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed