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Quality Assurance Batch Record Review Jobs (NOW HIRING)

INCOG

Senior QA Batch Disposition Specialist

Fishers, IN

$77K - $106K/yr

Lead full lifecycle review and disposition of parenteral manufacturing batch records (Formulation ... Manage QA Hold status and serve as the primary QA point of contact for client-facing disposition ...

INCOG

QA Batch Review Specialist

Fishers, IN

Provide Client access and support in the review and approval of Batch Records. Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review ...

Abzena Inc.

QA Specialist

San Diego, CA · On-site

$90K - $125K/yr

The QA Operations Specialist will support the Abzena operations teams to drive continuous ... Be an SME of batch record review and disposition of buffers / media manufactured by Abzena.

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How much do quality assurance batch record review jobs pay per hour?

As of Aug 26, 2026, the average hourly pay for quality assurance batch record review in the United States is $29.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.75 and $34.38 per hour, depending on experience, location, and employer.

What is quality assurance batch record review?

Quality Assurance Batch Record Review is a process in which QA professionals examine manufacturing batch records to ensure that all production and quality control steps have been completed according to regulatory standards and company procedures. This review helps to identify any discrepancies, deviations, or errors before products are released for distribution. By meticulously checking documentation, QA specialists help maintain product integrity, regulatory compliance, and patient safety. The role is essential in the pharmaceutical, biotech, and manufacturing industries.

What are some common challenges faced during quality assurance batch record review, and how can they be managed?

One common challenge in Quality Assurance Batch Record Review is identifying and resolving discrepancies or incomplete documentation within batch records, which can slow down release timelines. To manage this, QA professionals often work closely with production and laboratory teams to clarify issues and ensure thorough documentation. Another challenge is staying up-to-date with evolving regulatory requirements, which requires ongoing training and attention to detail. Effective communication, strong organizational skills, and a proactive approach to documentation can help overcome these hurdles and ensure compliance.

What are the key skills and qualifications needed to thrive as a quality assurance batch record review specialist, and why are they important?

To thrive as a Quality Assurance Batch Record Review specialist, you need a strong understanding of GMP regulations, pharmaceutical manufacturing processes, and a relevant science degree. Familiarity with electronic batch record systems, document management software, and regulatory compliance databases is typically required. Attention to detail, critical thinking, and effective communication are crucial soft skills for identifying discrepancies and ensuring compliance. These skills are vital to maintain product quality, meet regulatory standards, and prevent costly production errors.

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

AspectQuality Assurance Batch Record ReviewQuality Control Inspector
Primary FocusReviewing and approving batch records for compliance and accuracyInspecting products and materials for quality and defects
ResponsibilitiesEnsuring batch documentation meets regulatory standardsPerforming physical inspections and testing of products
CredentialsTypically requires QA certifications, GMP knowledgeOften requires quality control or lab certifications
Work EnvironmentOffice-based review, documentation-focusedManufacturing floor, lab testing environment

While both roles ensure product quality, the Quality Assurance Batch Record Review focuses on document review and compliance, whereas the Quality Control Inspector conducts physical product inspections. Both are essential for maintaining quality standards in manufacturing industries.

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Quality Assurance Batch Record Review jobs near you
Infographic showing various Quality Assurance 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, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $60,925 per year, or $29.3 per hour.

QA Batch Record Reviewer

VIVEX BIOLOGICS INC

Miami, FL

Full-time

Posted 5 days ago

Job description

Description

Job Purpose

The Quality Assurance (QA) Batch Record Reviewer performs the Technical and Final release function of the graft release process. The QA Batch Record Reviewer performs functions necessary to assure that all relevant manufacturing records are assembled, reviewed, and completed in a compliant efficient manner, and ultimately determines and documents the final disposition of each graft on the controlled batch records and in the VIVEX Biologics computer system. This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as all applicable state, regulatory and AATB requirements.


Duties and Responsibilities

  1. Responsible for meeting assigned goals in technical release review and final release of allografts, including, but not limited to:
  • Disposition, review, and verify tissue sent for irradiation and sterilization.
  • Confirm the relevant quality control results are within acceptable limits.
  • Ensure that each tissue is labeled per manufacturer's specification sheet (if required).
  • Confirm packaging integrity and final label(s) have passed appropriate inspection(s) prior to setting final disposition.
  • Review and complete records ensuring compliance with applicable SOPs, agency requirements and accreditation standards and regulatory regulations. 
  • Communicate with appropriate personnel on missing documentation and error corrections 
  • Monitor and track to completion of all work in progress (WIP) records.
  • Change in status of allografts in the inventory system 


2. Work closely with operations and customer service personnel on inventory needs for customer orders and back orders.

3. Knowledgeable of the VIVEX BTM computer system and able to perform all functions as required.

4. Responsible for reporting all variances, errors and deviations to Quality Assurance.

5. Able to collaborate on complaint and/or nonconformance reports according to VIVEX procedure. 

6. Performs other duties as assigned by the Manager and Director of the Department.


Requirements

Qualifications

  • AA or BS preferred. Basic computer skills necessary. Prefer a candidate a minimum of three years' experience in quality assurance, processing, distribution or inventory control departments.  
  • Candidate should be certified as a Tissue Bank Specialist by the American Association of Tissue Banks within 2 years of employment. 


Working Conditions

Primarily a quiet office-oriented work environment. Some evening and weekend work may be required to ensure customer commitments and goals are met.


Physical Requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.


Direct Reports

No direct reports.


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