QA Specialist II-Lot review
Core
Reviewing manufacturing batch records and associated documentation to ensure compliance with GMP and regulatory requirements.
Role type
QA Specialist II (Lot Review)
Builds
Manufacturing batch records and associated documentation
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, Good Documentation Practices (GDP), data integrity principles, discrepancy identification, regulatory expectations
Preferred skills
Audit/inspection support experience
Technologies
None stated
Responsibilities
Perform detailed review of manufacturing batch records and supporting documentation for completeness, accuracy, and compliance; Identify discrepancies, documentation errors, and GMP issues, and follow through to resolution; Escalate complex or unclear issues to senior QA team members as appropriate; Ensure all documentation aligns with Good Documentation Practices (GDP) and data integrity standards; Support timely batch disposition activities through efficient and thorough review; Participate in daily lot review/release meetings; Maintain clear and accurate documentation of review findings; Support audit and inspection readiness by ensuring records are complete and compliant; Collaborate with manufacturing and quality teams to clarify and resolve documentation issues
Seniority
Mid-level, hands-on IC