Quality Assurance – Batch Record Review Specialist

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.