Document Control / Record Control Lead

At ReviveRX, we exist for the patients who fall through the cracks of conventional medicine — the ones who need something more precise, more personal, more them.

As a leading licensed mail-order pharmacy specializing in both generic and compounded medications, we don't just fill prescriptions. We craft solutions. Every medication is tailored to the unique biology, needs, and life of a real person — because that's what personalized medicine actually means.

Our mission: Equip providers with safe, innovative options and deliver an exceptional experience from the moment a prescription is written to the moment it arrives at a patient's door.

Founded in 2016 and compounding since 2018, ReviveRX has built a team of dedicated professionals all driven by one uncompromising standard: excellence. We work closely with best-in-class pharmacists, scientists, healthcare providers, and pharmaceutical manufacturers to ensure every product we deliver is high-quality and dependable.

Quality isn't a checkbox here. It's our culture.

Our compounds are expertly crafted in USP-certified clean rooms at our Houston headquarters — built to meet the most rigorous standards in the industry. Every single batch undergoes sterility and endotoxin testing to ensure the highest levels of compliance, efficacy, and patient safety. We understand the trust providers place in us, and we honor that responsibility with precision and transparency. That trust isn't given. It's earned, every day.

Providers come to us for our clinical quality. They stay because of our service, our responsiveness, and the way we show up as true partners in care. Whether you're just exploring personalized medicine or you've been a compounding advocate for years — welcome to the ReviveRX difference.

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 

EQUAL OPPORTUNITY EMPLOYER 

ReviveRX is an equal opportunity employer committed to creating a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. 

Why Join ReviveRX? 

The best work happens when purpose meets opportunity. At ReviveRX, you'll work with a passionate, driven team that's redefining what pharmacy can be — with the resources, leadership, and culture to back it up. We offer competitive compensation, strong benefits, and real room to grow, lead, and make your mark.

ReviveRX is proud to be an equal opportunity employer. We are committed to building a diverse, inclusive workplace where every team member feels valued, respected, and empowered to do their best work.