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Qa 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 · On-site

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 qa batch record review jobs pay per hour?

As of Aug 29, 2026, the average hourly pay for qa 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 a QA Batch Record Review?

A QA Batch Record Review job involves reviewing manufacturing batch records to ensure compliance with company policies, regulatory requirements, and Good Manufacturing Practices (GMP). The role ensures that all documentation is accurate, complete, and meets quality standards before product release. Responsibilities may include identifying discrepancies, coordinating with production teams for corrections, and maintaining compliance with FDA or other regulatory guidelines. This position is essential in the pharmaceutical, biotechnology, and healthcare industries to ensure product safety and consistency.

What are the main responsibilities and challenges faced by someone in a QA Batch Record Review role?

A QA Batch Record Review professional is responsible for reviewing production and manufacturing records to ensure compliance with regulatory standards and identify any discrepancies or deviations. This role often requires meticulous attention to detail, as even small errors in documentation can impact product release or trigger audits. A key challenge is balancing thoroughness and efficiency under demanding production schedules. Typically, individuals in this role collaborate closely with production, quality assurance, and regulatory teams to resolve issues and maintain a smooth workflow. This position can offer career growth into broader quality assurance or compliance roles within the pharmaceutical or manufacturing industry.

What are the key skills and qualifications needed to thrive in the QA Batch Record Review position, and why are they important?

To thrive as a QA Batch Record Review specialist, you typically need a background in life sciences or a related field along with strong attention to detail and knowledge of Good Manufacturing Practices (GMP). Familiarity with electronic batch record systems, regulatory documentation, and quality control or assurance certifications are often required. Excellent analytical skills, effective communication, and the ability to work both independently and collaboratively are valuable soft skills in this position. These skills ensure that all production records are accurate, compliant, and meet quality standards, which is critical for maintaining product integrity in regulated industries.

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Qa Batch Record Review jobs near you
Infographic showing various Qa Batch Record Review job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 82% Full Time, 13% Part Time, and 3% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% 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 8 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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