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Contract Qa Batch Record Review Jobs (NOW HIRING)

Kellton Tech

Quality Associate - Raleigh, NC

Raleigh, NC · On-site

$30 - $33/hr

Raleigh, NC Duration: 12 months contract with possible extension Pay rate range: $30/hr-$33/hr Job ... Quality Assurance in an FDA-regulated industry. Experience with batch record review, document ...

Lonza

QA Specialist II-Lot review

Portsmouth, NH · On-site

QA Specialist II - Lot Review Location: This position is based in our Portsmouth, NH office. The ... Perform detailed review of manufacturing batch records and supporting documentation for ...

Alan Baird Industries

Batch Record Reviewer

Allendale, NJ · On-site

$19 - $22/hr

Review batch records and travelers for completeness, accuracy, and compliance. * Release product in accordance with internal procedures and quality standards. * Ensure all documentation adheres to ...

Actalent

QA Associate

Clinton, IN

Experience with batch record review and batch record maintenance. * Knowledge of cGMP principles ... Job Type & Location This is a Contract to Hire position based out of Clinton, IN. Pay and Benefits ...

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How much do contract qa batch record review jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for contract 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 are some common challenges faced in a contract QA batch record review role, and how can they be managed?

In a Contract QA Batch Record Review position, one of the most common challenges is managing tight deadlines while ensuring meticulous attention to detail. Batch records often contain complex information, and discrepancies or omissions must be identified and addressed promptly to maintain compliance with regulatory standards. Effective communication with production and quality teams is crucial for resolving issues quickly. Staying organized, prioritizing tasks, and maintaining up-to-date knowledge of relevant regulations can help streamline the review process and minimize errors.

What are the key skills and qualifications needed to thrive as a contract QA batch record reviewer, and why are they important?

To thrive as a Contract QA Batch Record Reviewer, you need a solid understanding of GMP regulations, pharmaceutical manufacturing processes, and experience with batch record documentation, often supported by a degree in life sciences or a related field. Familiarity with quality management systems (QMS), electronic batch record (EBR) systems, and regulatory compliance tools is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for identifying discrepancies and ensuring compliance. These competencies are vital for maintaining product quality, regulatory adherence, and minimizing production risks in pharmaceutical environments.

What is the difference between Contract Qa Batch Record Review vs Contract Quality Assurance Specialist?

AspectContract Qa Batch Record ReviewContract Quality Assurance Specialist
CertificationsGMP, GDP, ISO training, QA certificationsGMP, GDP, ISO training, QA certifications
Work EnvironmentPharmaceutical/biotech manufacturing, quality control labsPharmaceutical/biotech manufacturing, quality assurance departments
Primary ResponsibilitiesReviewing batch records for compliance, documentation accuracyOverseeing quality systems, audits, process validation

The Contract Qa Batch Record Review focuses specifically on reviewing batch documentation for compliance and accuracy during manufacturing. In contrast, the Contract Quality Assurance Specialist has broader responsibilities, including overseeing quality systems and conducting audits. Both roles require GMP knowledge and work within pharmaceutical or biotech environments, but the Batch Record Review is more task-specific, while the QA Specialist has a wider scope of quality management.

What is a contract QA batch record reviewer?

A Contract QA Batch Record Reviewer is a quality assurance professional who is hired on a contract basis to review and verify manufacturing batch records in industries like pharmaceuticals, biotechnology, or food production. Their main responsibility is to ensure that all production documentation complies with regulatory standards and company protocols before products are released. This role involves checking for accuracy, completeness, and consistency in records, identifying any discrepancies or deviations, and working with production teams to resolve issues. Contract-based reviewers may work with multiple clients and help ensure that all batches meet strict quality and safety requirements.
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Contract Qa Batch Record Review jobs near you
Infographic showing various Contract Qa 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 $60,925 per year, or $29.3 per hour.

Quality Assurance (QA) Engineer / Senior QA Specialist (TEST)

TiltEdge Solutions LLC

Raleigh, NC • On-site

Contractor

Re-posted 13 days ago

Job description

Quality Assurance (QA) Engineer / Senior QA Specialist (TEST)

Experience Required: 7–10 Years

Location: Raleigh, NC

Visa: US Citizen / Green Card

Mode of Work: In-office

Duration: 10 to 12 months +

Role Overview

The QA Engineer / Senior QA Specialist will provide experienced, hands-on quality oversight for commercial GMP manufacturing operations. This role requires strong judgment, deep knowledge of GMP regulations, and the ability to independently manage quality events while partnering closely with Manufacturing, Validation, and Engineering teams in a regulated environment.

Key Responsibilities

* Provide independent QA oversight for commercial GMP manufacturing operations in compliance with 21 CFR Parts 210/211, EU GMP, and ICH Q10.

* Own and manage deviations, CAPAs, and change controls in TrackWise, including leading investigations, performing root cause analysis, assessing product impact, and ensuring timely, effective closure.

* Review and approve validation and qualification documentation (including IQ/OQ/PQ, protocols, reports, and summary documentation) using Kneat, ensuring compliance with GMP, data integrity, and regulatory expectations.

* Perform thorough batch record review and release support, identifying trends, risks, and opportunities for process improvement.

* Support equipment lifecycle activities, including maintenance, calibration, and qualification, through review of GMP documentation and records in CMMS.

* Review, approve, and maintain controlled documents, SOPs, and training records in Veeva Vault, ensuring accuracy, compliance, and inspection readiness.

* Contribute to the development, revision, and continuous improvement of QA procedures, processes, and documentation to support operational readiness and manufacturing excellence in a cGMP facility.

* Serve as a QA point of contact for manufacturing operations, providing guidance on GMP expectations, deviation handling, and change implementation.

* Support regulatory inspections, internal audits, and customer audits, including preparation, participation, and follow-up actions.

* Mentor junior QA team members and provide guidance on GMP best practices, as needed.

Systems & Tools

* TrackWise – Deviations, CAPAs, Change Control

* Kneat – Validation, Qualification, Batch Record Review

* Veeva Vault – Document and Training Management

* CMMS – Equipment Maintenance and Calibration Records

Qualifications

* Bachelor’s degree in Science, Engineering, or a related discipline (or equivalent experience).

* 7–10 years of Quality Assurance experience in a cGMP-regulated environment (pharmaceutical, biotech, or related industry).

* Strong working knowledge of FDA, EU, and ICH GMP regulations.

* Proven experience independently managing quality investigations, change controls, and validation documentation.

* Experience supporting commercial manufacturing operations.

* Strong communication, documentation, and cross-functional collaboration skills.

* Demonstrated ability to work independently while balancing multiple priorities in a fast-paced GMP environment