Document Control Specialist

Strive Pharmacy • Alachua, FL

4d • $50,000 - $60,000 • Onsite

About The Position

The Document Control Specialist is a member of the Quality Assurance team and collaborates with all other departments. Working within the Quality Management System with a focus on documentation, ensuring that all controlled documents (Standard Operating Procedures (SOP), batch records, policies, and forms) are current, accurate, traceable, and compliant with FDA, USP, and CGMP standards.

Requirements

• 2+ years of CGMP experience in document control, quality assurance, or a regulated industry (pharmaceutical, compounding, biotech, or medical device preferred).
• Familiarity with USP <795>, <797>, <800> standards and/or FDA cGMP regulations.
• Experience working in electronic quality management systems (deviations, CAPA, and change control).
• Experience working within an electronic or paper based document management system.
• Exceptional attention to detail.
• Strong organizational skills and the ability to manage multiple document workflows simultaneously.
• Clear, concise written communication.

Nice To Haves

• Experience in a compounding pharmacy or 503B outsourcing facility.
• Familiarity with PCAB accreditation or ISO quality systems.
• Experience implementation/maintenance of an electronic quality management system including management of electronic batch records, forms, and protocols.
• Experience supporting FDA inspections or state pharmacy board audits.

Responsibilities

• Own the full lifecycle of controlled documents: creation, review, approval, distribution, tracking archival and retirement.
• Maintain and continuously improve the document management system (DMS).
• Assists users of the document management system (DMS) in creation, review, and approval workflows across departments.
• Ensure SOPs, work instructions, batch records, and forms are formatted to align with Strive templates.
• Train staff on document control procedures and compliance requirements.
• Support internal audits, regulatory inspections, and external accreditation reviews.
• Identify and resolve documentation gaps before they become problems.
• Partner with other quality personnel, operations, pharmacy, and engineering/facility teams to keep documentation aligned with actual practice.
• Manage change controls, deviation records, and CAPAs related to documentation and the electronic document management system.
• Any other duties required as defined by management.

Benefits

• Employer paid healthcare coverage available after 30 days of employment
• Choice of an FSA/HSA
• Parental leave
• 401(k) plan with matching contributions
• FREE COMPOUNDED MEDS to employees and immediate family members

What This Job Offers

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