Batch Record Reviewer

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. 

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. 

ReviveRX'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. 

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 

•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 

•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 

•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 

•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 

•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 

•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 

•Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, or related scientific field - REQUIRED 

•Advanced degree (Master’s, PharmD) preferred but not 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 

•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) 

This is an on-site position based in Houston, Texas, requiring daily presence to review batch records, interact with production and quality teams, and access manufacturing documentation. Standard business hours (typically first shift) with flexibility to support second shift operations to accommodate production needs. The role is primarily desk-based with computer work reviewing documentation, though occasional presence in production areas may be required to investigate discrepancies or observe processes. The position involves sustained focus and attention to detail, often reviewing multiple batch records per day in a fast-paced environment. 

•Complete onboarding and demonstrate proficiency in ReviveRX batch record review procedures within 90 days 

•Independently review and disposition batches within established cycle time targets 

•Achieve zero critical findings related to batch record reviews during internal or external audits 

•Provide measurable support to junior team members through mentoring and knowledge sharing 

•Reduce manager’s hands-on batch review involvement by taking ownership of complex or high-risk batches 

•Successfully support the onboarding and ramp-up of second shift production without quality compromises 

•Contribute at least 2-3 process improvement recommendations that enhance review efficiency or documentation quality 

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.

Revive RX is committed to providing equal employment opportunities and render affirmative action to all employees and applicants for employment, including individuals who are members of underrepresented groups, without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other status protected by applicable federal, state, or local laws. 

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.