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Overnight Qa Batch Record Review Jobs (NOW HIRING)

AbbVie

PR · On-site

The Specialist, Quality Assurance is responsible for QA batch record review and disposition ... The batch record review encompasses manufactured batch records, investigation of deviations ...

Kelly Services

Overnight QA Supervisor

Lancaster, SC

$75K - $85K/yr

... overnight QA team in a fast-paced, FDA-regulated manufacturing environment. This role is ... Review batch records, production documentation, and quality records for accuracy and compliance.

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.

Abzena

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.

Abzena

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 overnight qa batch record review jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for overnight qa batch record review in the United States is $31.24, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $36.54 per hour, depending on experience, location, and employer.

What are some common challenges faced by overnight QA batch record reviewers, and how can they be managed?

Overnight QA Batch Record Reviewers often encounter challenges such as managing tight turnaround times, maintaining focus during late hours, and ensuring meticulous attention to detail to catch discrepancies in manufacturing records. Working independently with limited on-site support can also present difficulties when resolving urgent issues. To manage these challenges, it's important to develop strong organizational skills, familiarize yourself thoroughly with SOPs, and maintain clear communication with both day-shift and night-shift teams for effective handovers and issue escalation.

What is an overnight QA batch record reviewer?

An Overnight QA Batch Record Reviewer is a quality assurance professional responsible for reviewing manufacturing batch records during overnight shifts. This role ensures that all documentation related to production batches is complete, accurate, and compliant with regulatory standards before product release. By working overnight, they help maintain continuous production flow and timely product release in facilities that operate around the clock. Their work is critical in identifying and resolving documentation errors or discrepancies, ensuring product quality and regulatory compliance.

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

To thrive as an Overnight QA Batch Record Reviewer, you need a solid understanding of GMP regulations, quality assurance principles, and experience in reviewing pharmaceutical or biotech manufacturing documentation. Familiarity with electronic batch record systems, quality management software, and relevant certifications such as Six Sigma or ASQ are often required. Attention to detail, strong analytical thinking, and effective communication are standout soft skills for identifying discrepancies and collaborating across shifts. These skills and qualifications are vital to ensure product quality, regulatory compliance, and uninterrupted production during overnight operations.

What is the difference between Overnight Qa Batch Record Review vs Quality Assurance Technician?

AspectOvernight Qa Batch Record ReviewQuality Assurance Technician
CredentialsTypically requires GMP/GxP knowledge, QA certificationsSimilar certifications, often GMP/GxP experience
Work EnvironmentPharmaceutical or biotech manufacturing, night shiftManufacturing, laboratory, or production settings
Job FocusReview and approve batch records during overnight shiftPerform quality checks, audits, and documentation

The Overnight Qa Batch Record Review primarily involves reviewing batch documentation during the night shift to ensure compliance, while the Quality Assurance Technician performs broader quality checks and audits across manufacturing processes. Both roles require GMP knowledge and are essential in maintaining product quality in pharmaceutical industries.

What cities are hiring for Overnight Qa Batch Record Review jobs?

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What are the most commonly searched types of Qa Batch Record Review jobs?

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Overnight Qa Batch Record Review jobs near you

Quality Assurance - Batch Record Review Specialist with Security Clearance

Beacon Hill

Albany, NY • On-site

Other

Posted 2 days ago

New

Job description

The Quality Assurance Batch Record Reviewer is responsible for the complete, accurate, and compliant review of batch production records for sterile drug products manufactured in a 503B outsourcing facility. This role performs QA review of documentation, data integrity, verifies adherence to CGMP and aseptic processing requirements, and supports timely batch release. The Reviewer works closely with Manufacturing, Quality Control, and Compliance to maintain audit-ready documentation and uphold sterility assurance standards. Key Responsibilities Batch Record Review & Documentation Control * Perform detailed review of Batch Production Records (BPRs), ensuring completeness, accuracy, and compliance with CGMP and 503B requirements. * Verify all critical manufacturing steps, in-process checks, component usage, equipment logs, and operator entries. * Ensure reconciliation of materials, components, and labels. * Review associated documentation including EM results, equipment calibration, sterilization records, and deviation reports. Aseptic Processing Compliance * Confirm documentation supports aseptic technique, cleanroom behavior, and contamination control expectations. * Ensure all required pre- and post-processing checks (line clearance, equipment setup, environmental conditions) are properly documented. * Validate that manufacturing of batches meet acceptance criteria. Deviation, Investigation & Change Control Support * Identify documentation gaps, errors, or potential deviations during record review. * Initiate and support investigations related to batch discrepancies, EM excursions, or equipment issues. * Collaborate with QA and Operations to ensure corrective actions are documented and effective. Batch Release Support * Prepare batch record review summaries and release recommendations for QA management. * Ensure all required supporting documents are present, accurate, and audit-ready. * Maintain strict adherence to batch release timelines. Data Integrity & Compliance * Ensure all documentation meets ALCOA+ data integrity principles. * Maintain controlled forms, logs, and templates in accordance with document control procedures. * Support internal audits and FDA inspections by presenting documentation and responding to technical questions. Qualifications * Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or related field. * 3-5 years of experience in aseptic pharmaceutical manufacturing, sterile injectable(s), 503B manufacturing. * Knowledge and understanding of CGMP, Annex 1, USP / / , and FDA 503B guidance. * Experience reviewing batch records, manufacturing documentation, or QA compliance records. * Excellent attention to detail and strong documentation discipline. * Ability to interpret manufacturing processes, equipment logs, and aseptic workflow requirements. Competencies * High accuracy and attention to detail. * Strong communication skills and ability to work cross-functionally. * Ability to identify documentation gaps and drive resolution. * Comfortable working in a fast-paced, highly regulated environment. * Commitment to sterility assurance and contamination control.

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