POSITION SUMMARY:
The Sr. Specialist, QA Batch review is a senior-level position responsible for leading the comprehensive review of complex batch production records and associated documentation to ensure compliance with FDA, EMA, and internal QMS requirements prior to product disposition and release. Serves as a technical subject matter expert (SME) for batch record review, provides mentorship to junior specialists, drives quality system improvements, and represents QA during internal and regulatory inspections within a CDMO environment.
PRINCIPAL DUTIES:
Advanced Batch Record Review
-
Independently conduct thorough review of complex executed batch records and all associated documents (testing reports, deviations, cleaning records, equipment logs) for completeness, accuracy, clarity, and regulatory compliance.
-
Review and approve draft batch records prior to manufacturing to ensure clarity and compliance.
-
Verify critical process parameters, in-process controls, and documentation for high-risk or complex product campaigns.
-
Final responsibility for verifying that batch record information is complete prior to batch record release.
-
Apply a risk-based approach to prioritize review activities and escalate critical findings appropriately.
-
Ensure timely and compliant review to meet manufacturing, supply chain, and client cycle time demands.
-
Oversee creation and scanning of batch record package binders and ensure archival accuracy.
Deviation, CAPA & Change Control
-
Lead or support the review, investigation, and closure of deviations impacting batch quality.
-
Drive CAPA development, implementation, and effectiveness checks related to systemic batch record errors.
-
Review and approve change control documentation affecting batch record processes.
-
Report nonconformances and lead escalation and resolution efforts.
-
Proactively identify quality risks and implement mitigation strategies or escalate as needed.
Mentoring & Training
-
Provide technical guidance and mentorship to Associate Specialist and Specialist (L1 & L2).
-
Assist in onboarding, training, and competency evaluation of junior specialists.
-
Foster a culture of accountability, continuous improvement, and collaboration within the team.
Compliance, Audits & Inspections
-
Serve as SME for batch record review during internal audits and external regulatory inspections (FDA, EMA, client audits).
-
Support preparation of responses to audit observations related to batch record review.
-
Ensure strict adherence to regulatory standards (FDA, EMA, ICH, ISO, GMP) and ALCOA+ principles.
Process Optimization & Cross-Functional Collaboration
-
Identify systemic inefficiencies in QA workflows and lead implementation of improvements.
-
Partner with manufacturing, R&D, supply chain, and regulatory affairs to embed quality throughout the product lifecycle.
-
Assist in the development, revision, and approval of SOPs related to batch record review and product release.
-
Track and report KPIs related to batch record review performance to QA leadership.
-
May perform other duties as assigned.
JOB REQUIREMENTS:
-
Expert-level knowledge of cGMP (US, EU, ICH) regulations and manufacturing processes (Form/Fill, Visual Inspection, Packaging, Utilities).
-
Advanced proficiency in quality systems: Deviation, CAPA, Change Control, OOS/OOT, Document Control, and Material Review.
-
Demonstrated ability to lead complex investigations and implement effective CAPAs.
-
Strong risk management and decision-making skills.
-
Proven ability to present technical information and regulatory compliance data to senior management and regulatory agencies.
-
Excellent verbal, written, and organizational communication skills.
-
Ability to mentor and develop junior staff effectively.
-
Proficient in continuous improvement methodologies (e.g., PDCA, Six Sigma, Lean).
-
Strong analytical and problem-solving skills with attention to detail.
-
Must demonstrate integrity, accountability, sound judgment, intellectual honesty, and an uncompromising commitment to quality.
-
Proficient in eQMS platforms and Microsoft Office Suite.
EDUCATION and/or EXPERIENCE:
-
Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field required.
-
5–8 years of progressive experience in batch record review and/or product release in a GMP-regulated environment.
-
Demonstrated experience in CDMO or pharmaceutical manufacturing operations.
-
Experience supporting regulatory inspections (FDA, EMA) as a subject matter expert preferred.
-
Strong analytical, organizational, and communication skills with a proven track record of leading quality improvements.
Physical Requirements
-
Ability to lift and carry boxes or binders weighing up to 25 lbs.
-
Ability to stand, walk, and move between departments or storage areas as part of regular duties.
