Document Control​/Record Control Lead

Overview

ReviveRX is the premier licensed pharmacy specializing in health, wellness, and restorative medicine. We focus on treating the source, not just the symptoms, utilizing industry-leading technology. Collaborating with innovative pharmacists, healthcare providers, and pharmaceutical manufacturers, we provide personalized care. Our mission is to optimize treatment, revolutionize healthcare, and empower individuals to live vibrant lives. We welcome you to join us in our commitment to holistic wellness and personalized medicine.

POSITION OVERVIEW

The Document Control/Record Control Lead is a critical role responsible for managing and maintaining the comprehensive Quality Management System (QMS) documentation and records management system s role ensures compliance with regulatory requirements, compounding quality standards, and internal procedures. The Document Control Specialist plays a crucial role in maintaining accurate and up-to-date documentation, supporting efficient processes, and contributing to overall product quality.

This position will serve as the central hub for the upkeep, maintenance, and control of all QMS 503A documentation including SOPs, forms, work instructions, batch records, testing records, and other critical documents. With a large volume of documents generated daily across operations, facilities, quality, and other functions, this role ensures documents are properly controlled, easily retrievable, inspection-ready, and effectively support knowledge management across the organization.

The ideal candidate brings 5-10 years of regulated industry experience, exceptional organizational skills, and the ability to learn, adapt, and collaborate effectively across all functional areas.

• Document Management & Control: Manage the daily deluge of documents used at Revive
  
  RX including SOPs, forms, work instructions, batch records, testing records, specifications, and other controlled documents.
• Document control system maintenance: Maintain the master document control system ensuring all documents and records are properly numbered, versioned, and tracked.
• Workflow management: Process document creation, revision, approval, and distribution workflows (e.g., SOPs, Work Instructions, Forms, etc.) according to established procedures.
• Version control: Ensure only current, controlled and approved versions of documents are in use and obsolete versions are properly retired.
• Distribution coordination: Coordinate electronic and physical document distribution to appropriate personnel and work areas.
• Metadata management: Manage document control database/system and maintain accurate metadata for all controlled documents.

• Periodic Review Management: Manage the timely periodic review of documents (SOPs, forms, etc.) by functional personnel to ensure documents remain fit-for-use.
• Scheduling & tracking: Coordinate with operations, facilities, quality, and other departments to schedule and track periodic reviews.
• Deadlines & escalation: Monitor review deadlines and proactively follow up with document owners to ensure timely completion per SOP requirements.
• Tracking & prevention of overdue items: Maintain review schedules and tracking systems to prevent documents from becoming overdue.
• Reporting: Generate reports on review status and escalate overdue items to management.
• Continual improvement: Ensure periodic reviews are performed to ensure continual improvement of the overall quality management system.

• Records Filing & Archival Management: Manage the filing and record management of completed documents in an orderly manner that is easily retrievable and defensible during inspections.
• Filing structures: Establish and maintain systematic filing structures for all records including batch records, testing records, deviations, CAPAs, and other quality records.
• Compliance: Ensure all records are filed promptly, accurately, and in accordance with regulatory requirements and company procedures.
• Storage systems: Manage both physical and electronic record storage systems with appropriate indexing for rapid retrieval.
• Archiving: Archive records according to retention schedules and regulatory requirements.
• Chain of custody: Maintain chain of custody and ensure security and integrity of all controlled and records.

• Inspection & Audit Support: Ensure critical accuracy for inspections and audits by getting the right document to the investigator or auditor in a timely manner.
• Point of contact: Serve as primary point of contact for document and record retrieval during state or federal regulatory inspections, audits, and investigations, as well as internal or external audits.
• Inspection-ready packages: Prepare inspection-ready document packages and ensure all required documentation is readily accessible.
• Response readiness: Respond rapidly and accurately to document requests from inspectors and auditors.
• Traceability: Maintain comprehensive document and record traceability to support regulatory compliance and quality investigations, in…