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Qa Batch Record Review Jobs (NOW HIRING)

Actalent

Quality Assurance Specialist

Madison, WI

$62K - $90K/yr

Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements. * Inspect and approve incoming raw materials to ensure they meet established ...

Kellton Tech

Quality Associate - Raleigh, NC

Raleigh, NC · On-site

$30 - $33/hr

... in batch record reviews to ensure documentation is complete, compliant, and ready for release. Support release activities by coordinating documentation readiness and collaborating with QA team ...

PCI Pharma Services

Qa Specialist Ii - Ops

Bedford, NH · On-site

Quality Assurance Reporting To: QA Manager / QA Director Responsible For (Staff): No The QA ... Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality ...

Eisai, Inc.

QA Specialist (Hybrid)

Raleigh, NC · On-site

$66K - $86K/yr

This role contributes to batch record review, documentation management, investigation support, and ... The QA Specialist, EMQO works collaboratively with internal stakeholders and business partners ...

Eisai

QA Specialist (Hybrid)

Raleigh, NC · Hybrid

$66K - $86K/yr

This role contributes to batch record review, documentation management, investigation support, and ... The QA Specialist, EMQO works collaboratively with internal stakeholders and business partners ...

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

As of Aug 7, 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 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.

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.

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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 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.

Senior Specialist, Quality Assurance

Allakos

Redwood City, CA • On-site

$95K - $131K/yr

Full-time

Re-posted 14 days ago

Job description

Senior Specialist, Quality Assurance
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.
Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Your Role:
  • Perform master batch record review and executed batch record review.
  • Support activities for dispositioning clinical and commercial bulk drug products and finished drug products.
  • Support the change management process, ensuring compliance with cGMP.
  • Assist in quality investigation of manufacturing/packaging deviations.
  • Assist in GMP audits, as required.
  • Assist in supplier qualification and reassessment activities.
  • Support the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.
  • Review and updates GMP related SOPs and policies
  • Participate in projects that support continuous improvement efforts.
  • CMO oversight of packaging contractors. Support manufacturing and packaging validation activities as well as commercial launch activities.
  • Participate in interactions with external service providers, as applicable.
  • Some travel is required, domestic and international.
Qualifications and Expertise:
  • At least 4 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
  • Bachelor's degree or higher
  • Working knowledge and understanding of ICH, FDA, and EU regulations
  • Working experience in GMP environment.
  • Excellent communication skills, both oral and written.
  • Excellent interpersonal skills, collaborative approach essential.
The salary is competitive and commensurate with experience and qualifications.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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About Allakos

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Redwood City, CA, US

Year founded

2012

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