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Evening Qa Batch Record Review Jobs (NOW HIRING)

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 ...

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 ...

Quality Assurance Specialist (Entry-Level) Location: Burlington, MA and Cambridge, MA Industry ... Perform batch record reviews and ensure proper chain of custody documentation is maintained.

... assurance, batch record review, audit readiness, quality management systems, Gmp, Compliance, iso 9001, Document control Top Skills Details Quality assurance,batch record review,audit readiness ...

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Evening Qa Batch Record Review information

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

As of Aug 16, 2026, the average hourly pay for evening 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 an evening QA batch record review?

An Evening QA Batch Record Reviewer is a quality assurance professional who reviews and verifies manufacturing batch records during the evening shift, ensuring all documentation is accurate and compliant with regulatory standards. Their role is critical in pharmaceutical, biotech, or manufacturing environments where products must meet strict quality guidelines before release. They check for errors or discrepancies in the records, confirm that all processes were followed correctly, and may communicate with production staff to resolve any issues. Their work helps maintain product quality and regulatory compliance.

What are some typical challenges faced in the evening QA batch record review role, and how can they be effectively managed?

Professionals in the Evening QA Batch Record Review role often encounter challenges such as tight turnaround times for reviewing documentation, managing incomplete or inconsistent records, and coordinating with production and quality teams working different shifts. Effective time management, strong attention to detail, and proactive communication with cross-functional teams are crucial for resolving discrepancies efficiently. Building a thorough understanding of standard operating procedures and maintaining organized review systems can also help ensure compliance and reduce errors.

What are the key skills and qualifications needed to thrive as an evening QA batch record reviewer?

To succeed as an Evening QA Batch Record Reviewer, you need a solid understanding of GMP regulations, quality assurance principles, and experience with pharmaceutical or manufacturing batch records, typically supported by a relevant degree. Familiarity with document management systems, electronic batch record (EBR) software, and QA auditing tools is often required. Strong attention to detail, analytical thinking, and effective communication are critical soft skills for this position. These competencies ensure accurate documentation review, regulatory compliance, and support for continuous quality improvements during evening operations.

What is the difference between Evening Qa Batch Record Review vs Quality Control Analyst?

AspectEvening Qa Batch Record ReviewQuality Control Analyst
Primary RoleReview and approve batch records during evening shifts to ensure compliancePerform laboratory testing and analysis of samples to ensure product quality
Work EnvironmentOffice or QA department during evening hoursLaboratory setting, often during day shifts
CertificationsGMP, GMP-related training, sometimes QA-specific certificationsLab certifications, GMP, and relevant technical training

The Evening Qa Batch Record Review focuses on reviewing batch documentation during evening hours to ensure compliance, while the Quality Control Analyst conducts laboratory testing to verify product quality. Both roles require GMP knowledge and related certifications but differ in daily tasks and work environment.

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

Cities with the most Evening Qa Batch Record Review job openings:

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

The most popular types of Qa Batch Record Review jobs are:

What states have the most Evening Qa Batch Record Review jobs?

States with the most job openings for Evening Qa Batch Record Review jobs include:

Quality Assurance - Batch Record Review Specialist with Security Clearance

Beacon Hill

Albany, NY • On-site

Other

Posted 4 days ago


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.