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
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Perform detailed review of Batch Production Records (BPRs), ensuring completeness, accuracy, and compliance with CGMP and 503B requirements.
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Verify all critical manufacturing steps, in‑process checks, component usage, equipment logs, and operator entries.
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Ensure reconciliation of materials, components, and labels.
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Review associated documentation including EM results, equipment calibration, sterilization records, and deviation reports.
Aseptic Processing Compliance
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Confirm documentation supports aseptic technique, cleanroom behavior, and contamination control expectations.
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Ensure all required pre‑ and post‑processing checks (line clearance, equipment setup, environmental conditions) are properly documented.
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Validate that manufacturing of batches meet acceptance criteria.
Deviation, Investigation & Change Control Support
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Identify documentation gaps, errors, or potential deviations during record review.
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Initiate and support investigations related to batch discrepancies, EM excursions, or equipment issues.
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Collaborate with QA and Operations to ensure corrective actions are documented and effective.
Batch Release Support
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Prepare batch record review summaries and release recommendations for QA management.
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Ensure all required supporting documents are present, accurate, and audit‑ready.
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Maintain strict adherence to batch release timelines.
Data Integrity & Compliance
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Ensure all documentation meets ALCOA+ data integrity principles.
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Maintain controlled forms, logs, and templates in accordance with document control procedures.
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Support internal audits and FDA inspections by presenting documentation and responding to technical questions.
Qualifications
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Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or related field.
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3-5 years of experience in aseptic pharmaceutical manufacturing, sterile injectable(s), 503B manufacturing.
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Knowledge and understanding of CGMP, Annex 1, USP <797>/<800>/<825>, and FDA 503B guidance.
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Experience reviewing batch records, manufacturing documentation, or QA compliance records.
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Excellent attention to detail and strong documentation discipline.
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Ability to interpret manufacturing processes, equipment logs, and aseptic workflow requirements.
Competencies
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High accuracy and attention to detail.
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Strong communication skills and ability to work cross‑functionally.
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Ability to identify documentation gaps and drive resolution.
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Comfortable working in a fast‑paced, highly regulated environment.
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Commitment to sterility assurance and contamination control.
Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.
California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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Company Profile:
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com.
Benefits Information:
Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.
We look forward to working with you!
Beacon Hill. Employing the Future™
