Thermo Fisher Scientific
BMR Reviewer Specialist
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
- Able to lift 40 lbs. without assistance
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Office
Job Description
The Role
We are seeking 4 Batch Record Reviewer – Documentation Specialists to join our Production team. This role provides critical support for batch record review, production documentation, and training activities within a GMP-regulated manufacturing environment.
You will help ensure that Batch Manufacturing Records (BMRs) and associated production documentation are accurate, complete, compliant, and reviewed in a timely manner. Working closely with Production and cross-functional teams, you will identify documentation issues and trends, provide feedback and coaching, and drive improvements in documentation quality and right-first-time performance.
As manufacturing operations run continuously, this position operates on a 24/7 rotating shift pattern, which may include days, nights, weekends, and public holidays.
Key Responsibilities
In this role, you will:
- Review Batch Manufacturing Records (BMRs) for accuracy, completeness, and compliance with GMP and data integrity requirements.
- Identify and trend batch record errors, providing timely feedback and coaching to Production operators to support continuous improvement and right-first-time documentation.
- Track the progress and status of batch record reviews, ensuring records are progressed and completed within required timelines.
- Ensure timely closure of batch manufacturing steps within SAP.
- Provide day-to-day documentation support to Production teams.
- Draft and maintain manufacturing documentation, including Master Batch Records, in collaboration with Technology Transfer, Cleaning & Process Validation, and other relevant functions.
- Author and review controlled production documentation, including Standard Operating Procedures (SOPs), training forms, risk assessments, and audit trail reviews using the Electronic Document Management System (EDMS).
- Coordinate investigations relating to documentation errors and support the identification and implementation of appropriate corrective and preventive actions.
- Own and progress change controls relating to Batch Manufacturing Records and associated production documentation.
- Attend Tier 1 huddles and provide clear updates on batch record review status, priorities, risks, and outstanding actions.
- Support and deliver training to Production personnel on good documentation practices and the correct completion of manufacturing documentation.
- Apply Practical Process Improvement (PPI) principles and tools to improve batch record processes, documentation quality, and overall operational effectiveness.
- Work collaboratively with Production, Quality, Technology Transfer, Validation, and other stakeholders to ensure documentation supports safe, compliant, and efficient manufacturing operations.
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Minimum Requirements / Qualifications
To be successful in this role, you should have:
- Proven working knowledge of Good Manufacturing Practice (GMP) principles and guidelines, particularly as they relate to manufacturing activities, documentation, and data integrity.
- Some experience working within a pharmaceutical, biopharmaceutical, medical device, or similarly regulated manufacturing environment.
- Some experience reviewing or completing controlled manufacturing documentation and/or Batch Manufacturing Records.
- Strong attention to detail with the ability to identify documentation errors, discrepancies, and compliance risks.
- Good written and verbal communication skills, with the confidence to provide constructive feedback and training to Production colleagues.
- Strong organizational skills and the ability to manage multiple priorities in a fast-paced manufacturing environment.
- Strong proficiency in Microsoft Office applications and a high level of general computer literacy.
- The ability and flexibility to work a 24/7 rotating shift pattern, including day and night shifts, weekends, and public holidays.
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Preferred Qualifications
The following would be advantageous:
- Experience within pharmaceutical manufacturing.
- Experience with sterile filtration products or sterile manufacturing processes.
- Experience using SAP and an Electronic Document Management System (EDMS).
- Experience with deviation investigations, CAPA, change control, or other pharmaceutical quality systems.
- Experience authoring or reviewing SOPs, Master Batch Records, risk assessments, or similar GMP-controlled documentation.
- Experience delivering training or coaching within a manufacturing environment.
- Knowledge of continuous improvement methodologies, including Practical Process Improvement (PPI), Lean, or similar approaches.
What Success Looks Like
You will play an important role in maintaining high standards of documentation and GMP compliance across Production. Success in this position means ensuring batch records are reviewed accurately and on time, documentation issues are identified and addressed effectively, and Production teams receive the support and training needed to continually improve documentation quality and right-first-time performance.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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