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Batch Record Review Jobs (NOW HIRING)

INCOG

QA Batch Specialist

Fishers, IN · On-site

Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product. Provide Client access and support in ...

Aerotek

Batch Maker

Riverton, NJ · On-site

$20 - $25/hr

Proficiency with batching documentation and batch record review in a CGMP and FDA-regulated environment. * Ability to use an RF scanner to track raw materials and finished products within an SAP or ...

Kellton Tech

Quality Associate - Raleigh, NC

Raleigh, NC · On-site

$30 - $33/hr

... batch record review, release activities, and building trackers to enhance operational efficiency. This position requires strong attention to detail, familiarity with document management systems such ...

Actalent

Quality Assurance Specialist

Norwood, MA

$42 - $52/hr

Support batch record review and release activities for materials and products. Review, investigate, and document deviations, ensuring appropriate corrective and preventive actions are implemented.

AbbVie

PR · On-site

The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports. Responsibilities: * Audit API, Bulk and/or finished Drug Product ...

Captek International

GDP Clerk

Vista, CA · On-site

Batch record review (daily): * Review PBR for GDP (Good Documentation Practices). * Verify all raw material used on the job Syspro and make any necessary transactions. * Reconcile the gelatin used on ...

Captek International

GDP Clerk

Vista, CA · On-site

$21 - $23/hr

Batch record review (daily): * Review PBR for GDP (Good Documentation Practices). * Verify all raw material used on the job Syspro and make any necessary transactions. * Reconcile the gelatin used on ...

Abzena Inc.

QA Specialist

San Diego, CA · On-site

$90K - $125K/yr

This individual will be a primary point of contact for Batch Disposition, Quality Control and Quality Record escalations and document review and approvals. Key responsibilities will include ...

Abbott

Quality Assurance Specialist

Pomona, CA · On-site

Perform batch record review, record administration, and batch release activities. * Review and generate Certificates of Analysis (COA) and Certificates of Conformance (COC). * Manage and track Change ...

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Batch Record Review information

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How much do batch record review jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for batch record review in the United States is $20.34, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $21.15 per hour, depending on experience, location, and employer.

What are common challenges faced in a batch record review role, and how can they be addressed?

One common challenge in a Batch Record Review role is ensuring the completeness and accuracy of documentation while working under tight deadlines, as production schedules often depend on timely batch release. Attention to detail is critical, since even minor discrepancies can lead to delays or compliance issues. Effective communication and collaboration with production, quality assurance, and laboratory teams are key to resolving discrepancies quickly. Proactively staying updated on current Good Manufacturing Practices (cGMP) and internal protocols can also help minimize errors and streamline the review process.

What is a batch record reviewer?

A Batch Record Reviewer is a quality assurance professional responsible for reviewing and verifying production batch records in pharmaceutical or manufacturing environments. Their main role is to ensure that all documentation related to the production of each batch complies with regulatory standards and company procedures. This includes checking for accuracy, completeness, and compliance with Good Manufacturing Practices (GMP). By doing so, they help maintain product quality and safety before products are released to the market.

What is the difference between Batch Record Review vs Quality Control Analyst?

AspectBatch Record ReviewQuality Control Analyst
Primary RoleReview and approve manufacturing batch records for compliance and accuracyPerform testing and analysis of raw materials, in-process, and finished products
CertificationsOften requires GMP, cGMP, or industry-specific certificationsRequires laboratory certifications, such as ASQ or equivalent
Work EnvironmentManufacturing or production facilities, quality assurance departmentsLaboratories, quality control labs, manufacturing sites
Industry UsagePharmaceutical, biotech, and manufacturing sectorsPharmaceutical, biotech, and food industries

While both roles focus on quality, Batch Record Review primarily involves reviewing manufacturing documentation for compliance, whereas Quality Control Analysts conduct testing and analysis to ensure product quality. Both are essential in regulated industries and often collaborate to maintain product standards.

What skills and qualifications are needed to be a batch record reviewer?

To thrive as a Batch Record Reviewer, you need strong attention to detail, knowledge of Good Manufacturing Practices (GMP), and experience in pharmaceutical or biotechnology documentation, often supported by a degree in life sciences or related fields. Familiarity with electronic document management systems (EDMS), quality management software, and regulatory compliance tools is typically required. Excellent analytical skills, organization, and effective communication are standout soft skills for this role. These abilities ensure the accuracy, compliance, and completeness of batch records, which are critical for product quality and regulatory approval.
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Batch Record Review jobs near you
Infographic showing various Batch Record Review job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, and 4% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $42,304 per year, or $20.3 per hour.

Master Batch Record (MBR) Designer - 1099/W2

GMP Pros, Inc.

Omaha, NE • Remote

Other

Re-posted 6 days ago

Job description

Are you a GMP Pro?!

  • Are you a proactive doer?
  • Do you need variety and change to keep from getting bored?
  • Do you build relationships easily and are you able to communicate information so that it is easily understandable?
  • Do you like working in a team supportive environment where others want to help you succeed?
  • Do you try to find a better way for everything because that is the way it should be?
  • Do you thrive in organized chaos and high-pressure situations?
  • Do you quickly become an expert in any subject matter you are working in?
  • Can you stay motivated and help motivate others in the face of adversity and change? Are you resilient?



The Master Batch Record (MBR) Designer will be presented with hard work, relentless challenges, and the pressure of high expectations. The MBR Designer is responsible for developing, configuring, and maintaining electronic Master Batch Records within a manufacturing execution system (MES) to support compliant and efficient production.


Be part of an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. Get the best of both worlds. Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company. 


APPLICANTS MUST HAVE PRIOR EXPERIENCE IN BIOTECH, PHARMACEUTICAL, OR ANIMAL HEALTH INDUSTRIES TO BE CONSIDERED


Essential Duties: 

  • Work with a project team to understand business requirements for design and deployment of PAS-X across manufacturing and packaging for Oral Solids Dosage.
  • Take design blueprints and translate into GMBRs, MBRs, PMBRs, PVLs, and ESPs for the deployment.
  • Support the creation and management of Master Data.
  • Support integration of hardware and infrastructure (printers, scanners, clients).
  • Test and troubleshoot designs with end users in the DEV environment.
  • Support verification and validation of designs in the PROD environment.
  • Support Early Life Support and Hyper Care for deployment activities across the site.
  • Maintain project deliverables and milestone dates.


Requirements: 

  • Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering, or a related technical field.
  • MES platform-based training or certification (e.g. Koerber PAS-X Training) preferred
  • 3 - 5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing with exposure to batch record development.
  • Minimum of 2 - 3 years of hands-on design experience with electronic batch record (eBR) systems such as PAS-X, Pharmasuite, Siemens opCenter, etc. (PAS-X preferred).
  • Proven experience mapping business processes (e.g. Visio or Lucid Chart)
  • Knowledge of GMP, FDA 21 CFR Part 11, and other relevant regulatory standards.
  • Practical experience working in a project environment with a project team.


Some other things that you will need to be successful:

  • Experienced in an FDA-regulated environment.
  • Excellent communication and organization skills, with an analytical and problem-solving mindset.
  • Ability to multi-task and complete multiple projects on time.

Pre-Employment Requirements: 

  • Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references.
  • Subject to motor vehicle report review.
  • Maintain valid driver’s license and endorsements as required per position.
  • Pass pre-employment/contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.
  • Successfully complete and maintain any required safety certification and testing on an annual basis.


Work Environment Expectations 

  • This role can be remote with occasional on-site work
GMP Pros logo

About GMP Pros

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

11 - 50 Employees

Headquarters location

Omaha, NE, US

Year founded

2013

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