Batch Record Reviewer

ReviveRX and Ways2Well • Houston, TX

2d • Onsite

About The Position

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 <797>, <795>, <800>, <1163>), 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.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, or related scientific field - REQUIRED
• 5-10 years of experience in the regulated industry (compounding and/or pharma) - REQUIRED
• Pharmaceutical industry experience preferred over compounding pharmacy
• Direct, hands-on experience reviewing batch records and making batch disposition decisions - REQUIRED
• Demonstrated experience in GMP-regulated manufacturing or compounding environments
• Background in quality assurance, quality control, or production within pharmaceutical/compounding operations
• Experience supporting regulatory inspections (FDA, state boards) with batch record presentations
• Deep knowledge of documentation requirements and batch record review standards
• Comprehensive understanding of USP <797>, USP <795>, USP <800>, as well as applicable State and Federal laws and regulations
• Familiarity with FDA regulations (21 CFR Parts 210, 211) for pharmaceutical manufacturing
• Knowledge of sterile and non-sterile compounding processes, formulations, and quality controls
• Understanding of deviation management, CAPA systems, and investigation methodologies
• Ability to interpret testing results, certificates of analysis (CoAs), and specifications
• Experience with both paper-based and electronic batch record systems
• Exceptional attention to detail with ability to identify discrepancies, errors, and documentation gaps
• Strong analytical and critical thinking skills to assess batch quality and disposition
• Sound judgment and decision-making capabilities for complex batch release scenarios
• Excellent organizational skills with ability to manage multiple tasks simultaneously
• Clear written and verbal communication skills for documentation and cross-functional collaboration
• Ability to work independently with minimal supervision while knowing when to escalate issues to management
• Sense of urgency balanced with thoroughness—understanding efficiency matters without compromising quality
• Collaborative mindset with willingness to mentor and support junior team members
• Treats colleagues with courtesy and dignity
• Communicates with tact, diplomacy, and professionalism
• Models a positive, solutions-oriented attitude
• Proficiency with Microsoft Office Suite (Excel for data review, Word for documentation)
• Experience with electronic quality management systems (eQMS) or electronic batch records (EBR)
• Familiarity with pharmacy management systems and laboratory information management systems (LIMS)
• Ability to perform pharmaceutical calculations and verify compounding math
• Comfortable learning new software systems and quality tools

Nice To Haves

• Advanced degree (Master’s, PharmD) preferred but not required
• Experience in 503A and/or 503B compounding operations
• Background in sterile injectable manufacturing or compounding
• Previous experience training or mentoring junior quality professionals
• Familiarity with continuous improvement methodologies (Lean, Six Sigma)

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 materials, review checklists, and standard operating procedures for batch record review
• Process Improvement & System Enhancement
• Identify opportunities to improve batch record templates, documentation clarity, and review efficiency
• Recommend enhancements to batch record review process and overall quality systems
• Participate in continuous improvement initiatives to reduce documentation errors and streamline reviews
• Contribute to the electronic batch record system and overall quality management systems (eQMS)
• Support trending and metrics tracking for batch record review cycle times, error rates, and disposition outcomes
• Regulatory Compliance & Audit Readiness
• Ensure all batch record reviews are conducted in compliance with USP <797>, USP <795>, USP <800>, as well as applicable State and Federal laws and regulations
• Maintain batch records and review documentation in an inspection-ready state
• Support regulatory inspections and audits by retrieving, presenting, and explaining batch records
• Aim to ensure timely completion of batch record reviews to help meet product release deadlines, with compliant batch records
• Participate in internal audits and mock inspections to verify batch record review processes, as required
• Production Support
• Manage batch record reviews efficiently while maintaining quality and accuracy
• Prioritize reviews based on production schedules, customer needs, and product stability considerations
• Adapt to the demands of a dynamic compounding operation
• Work collaboratively with other BRRs to balance workload and ensure timely product release
• Maintain composure and attention to detail, as required

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level