Batch Record Reviewer

Company Overview

At Revive RX, we're on a mission to transform healthcare by delivering exceptional, personalized wellness solutions through our state-of-the-art compounding pharmacy services. Headquartered in Houston, TX, we specialize in wellness optimization, hormone therapy, IV hydration, and performance-based medicine. Our team of passionate professionals is committed to advancing patient outcomes through innovation, collaboration, and excellence in everything we do. Join us as we continue to grow and shape the future of health and wellness.

POSITION OVERVIEW

The Batch Record Reviewer (BRR) is a critical quality assurance role responsible for conducting complete, timely and accurate reviews of compounding records (batch records) and supporting documentation to ensure compounded preparations are produced and documented in accordance with: applicable compounding standards (e.g., USP , , , ), state boards of pharmacy requirements, internal SOPs, master formulations, approved compounding processes, and overall Good Documentation Practices (GDPs).

This position serves as the final reviewer who approves product lots for release, making it essential to patient safety and regulatory compliance. The ideal candidate brings 5-10 years of experience in the regulated industry (compounding and/or pharma, with pharma preferred) and possesses deep expertise in batch record reviews and overall GMP documentation requirements and quality systems. This role will be part of an existing team of batch record reviewers.

BACKGROUND & NEED

Revive

RX's current team of batch record reviewers (BRRs) is in need of an additional team member to assist in accurate, timely and thorough reviews of these critical records. This role will join and strengthen an existing team, supporting the quality assurance function as production continues to scale.

KEY RESPONSIBILITIES

Batch Record Review & Product Release

Review compounding records (batch records) to ensure documentation is fit-for-use, complete, and accurate

Verify no errors are present in batch documentation, calculations, and supporting documentation, including, but not limited to: required signatures, correct ingredients, test results, beyond use dates, etc.

Confirm that the compounded product is produced as intended per the master formula, batch record, and applicable SOPs

Ensure all associated records (test results, nonconformances, investigations, CAPAs, deviations, etc.) are adequate, properly documented, and closed before the batch can be released

Serve as the final reviewer who approves product lots for release for dispensing-a critical patient safety and regulatory responsibility

Make defensible batch disposition decisions (approve, reject, hold for investigation) based on comprehensive documentation review

Documentation Verification & Compliance

Verify that all required documentation is present, complete, accurate, legible, and compliant with applicable state and federal laws and regulations, as well as USP standards

Review raw material receipt and testing documentation for conformance

Verify in-process checks, environmental monitoring, and process validations are documented and acceptable

Confirm finished product testing results meet specifications and quality standards

Ensure proper labeling, packaging, and storage documentation is complete and accurate

Verify all signatures, dates, and data entries are present and follow Good Documentation Practices

Quality Event Management & Investigation Review

Review deviations, investigations, and CAPAs associated with batches to ensure adequate root cause analysis and corrective actions

Assess whether deviations or quality events impact batch quality, safety, or efficacy

Verify that appropriate corrective and preventive actions are documented, completed, and have been completed and closed prior to the batch being approved for release

Escalate significant quality issues or trends to appropriate management within the QA function, as required

Participate in investigations when batch record discrepancies or anomalies are identified

Cross-Functional Collaboration

Work closely with compounding/production and dispensing teams to clarify documentation questions and ensure understanding of applicable regulatory requirements

Collaborate with Quality Control to review and reconcile testing results and certificates of analysis

Partner with Quality Assurance on trend analysis, CAPA effectiveness, and system improvements

Communicate batch holds, rejections, or issues to appropriate stakeholders in operations and quality

Support regulatory inspections by providing batch records and documentation as needed

Mentorship & Knowledge Sharing

Provide mentorship and guidance to junior batch record reviewers on technical review standards and best practices

Help build the capability and confidence of the existing staff through knowledge sharing and coaching

Share expertise on complex batch record review scenarios, deviation assessments, and disposition decisions

Contribute to training…