Reviverx2mo ago

Document Control / Record Control Lead

HoustonFull-Timelead

OtherDocument ControllerAdministration & Office Support

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Quick Summary

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.

Technical Tools

OtherDocument ControllerAdministration & Office Support

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 at ReviveRX. This 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.

KEY RESPONSIBILITIES

Document Management & Control

•Manage the daily deluge of documents used at ReviveRX including SOPs, forms, work instructions, batch records, testing records, specifications, and other controlled documents

•Maintain the master document control system ensuring all documents and records are properly numbered, versioned, and tracked

•Process document creation, revision, approval, and distribution workflows (e.g., SOPs, Work Instructions, Forms, etc.) according to established procedures

•Ensure only current, controlled and approved versions of documents are in use and obsolete versions are properly retired

•Coordinate electronic and physical document distribution to appropriate personnel and work areas

•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

•Coordinate with operations, facilities, quality, and other departments to schedule and track periodic reviews

•Monitor review deadlines and proactively follow up with document owners to ensure timely completion responsible (per SOP requirements)

•Maintain review schedules and tracking systems to prevent documents from becoming overdue

•Generate reports on review status and escalate overdue items to management

•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

•Establish and maintain systematic filing structures for all records including batch records, testing records, deviations, CAPAs, and other quality records

•Ensure all records are filed promptly, accurately, and in accordance with regulatory requirements and company procedures

•Manage both physical and electronic record storage systems with appropriate indexing for rapid retrieval

•Archive records according to retention schedules and regulatory requirements

•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

•Serve as primary point of contact for document and record retrieval during state or federal regulatory inspections, audits, and investigations by investigators, as well as internal or external audits

•Prepare inspection-ready document packages and ensure all required documentation is readily accessible

•Respond rapidly and accurately to document requests from inspectors and auditors

•Maintain comprehensive document and record traceability to support regulatory compliance and quality investigations, in close collaboration with other cross-functional subject matter experts

Knowledge Management & Accessibility

•Aid in knowledge management across the organization by maintaining well-organized, accessible document and record systems, and overall knowledge management

•Develop and implement search tools, indexing systems, and document maps to appropriately facilitate information retrieval

•Train personnel on document and record control procedures and how to access controlled documents

•Create and maintain document control metrics and reports for management visibility

•Identify opportunities to improve document and record management processes and systems

Cross-Functional Collaboration

•Work collaboratively across the organization with operations, facilities, quality, regulatory, and other functions

•Serve as document control subject matter expert and resource for all departments

•Coordinate with document authors and owners to ensure timely document processing

•Partner with IT and quality systems teams on the electronic document management system (under the company's eQMS) implementation and optimization

•Participate in cross-functional teams for process improvement initiatives

Compliance & System Maintenance

•Ensure document control practices comply with internal company policies, USP requirements, and State and Federal laws and regulations

•Maintain document control SOPs and work instructions to reflect good current practices

•Conduct periodic audits of document control systems to verify compliance and effectiveness and ensure continual improvement of the overall quality management system

•Manage electronic document management systems (EDMS) with appropriate access controls and audit trails

•Ensure Good Documentation Practices are adhered to throughout the document and record control systems

QUALIFICATIONS

Education

•High school diploma or equivalent required

•Associate's or Bachelor's degree preferred (any field)

•Formal training or certification in document control, records management, or quality systems a plus

Experience - CRITICAL REQUIREMENTS

•5-10 years of experience in a regulated industry (pharmaceutical, biotech, medical device, or compounding) – REQUIRED

•Direct document control and/or records management experience in a GMP environment

•503A and/or 503A or B compounding pharmacy experience a plus

•Experience managing large volumes of controlled documents and records

•Background supporting regulatory inspections with document retrieval and management

•Experience with electronic document management systems (EDMS) or quality management systems (QMS)

•Track record working in fast-paced pharmaceutical or compounding environments

Core Competencies – ESSENTIAL

•Exceptional organizational skills with meticulous attention to detail – CRITICAL

•Ability to learn and adapt quickly to new systems, processes, and technologies – CRITICAL

•Strong collaborative skills with ability to work effectively across all organizational functions – CRITICAL

•Systematic and methodical approach to managing high volumes of documentation

•Excellent time management with ability to prioritize multiple tasks and meet deadlines

•Proactive mindset with ability to identify and resolve issues and escalate to quality and operational leadership as required

•Strong sense of urgency, especially during inspections or critical document requests

•Treats colleagues with courtesy and dignity

•Communicates with tact, diplomacy, and professionalism

•Models a positive, solutions-oriented attitude

Technical Skills

•Proficiency with Microsoft Office Suite (Word, Excel, Outlook, SharePoint)

•Experience with electronic document management systems (e.g., MasterControl, TrackWise, Veeva Vault, or similar)

•Knowledge of document scanning, indexing, and archival technologies

•Knowledge of USP requirements for compounding pharmacies, including, but not limited to: USP <797> Pharmaceutical Compounding – Sterile Preparations, USP <795> Pharmaceutical Compounding – Non-Sterile Preparations, USP <800> Hazardous Drugs, and USP <1163> Quality Assurance in Pharmaceutical Compounding

•Familiarity with 21 CFR Part 11 requirements for electronic records

•Ability to create and maintain filing systems, databases, and tracking tools

Personal Attributes

•Highly dependable and reliable with strong work ethic

•Detail-oriented with zero tolerance for errors in document control

•Professional demeanor with excellent interpersonal skills

•Discrete and maintains confidentiality of sensitive information inherent to a highly regulated organization

•Flexible and adaptable to changing priorities and business needs

•Customer service mindset with focus on supporting internal stakeholders

•503A compounding pharmacy experience a plus

WORKING CONDITIONS

This is an on-site position based in Houston, Texas, requiring daily presence at the ReviveRX facility to manage physical and electronic document systems. The role involves work in both office and manufacturing environments. Standard working hours with flexibility required to support inspections, audits, and urgent document requests. Occasional overtime may be necessary during regulatory inspections or critical business periods. Physical requirements include ability to lift boxes of documents (up to 25 lbs), extended periods at computer workstations, and movement throughout facility to coordinate with various departments.

SUCCESS METRICS (FIRST 6-12 MONTHS)

•100% accuracy in document retrieval during inspections with timely response to investigator requests

•Reduction in overdue periodic document reviews through proactive tracking and follow-up

•Establishment of orderly, inspection-ready filing systems for all records

•Measurable improvement in document retrieval times for internal requests

•Zero findings related to document control during internal or external audits

•Positive feedback from functional areas on document control support and responsiveness