Batch Record Specialist
Core
Review and verify executed batch records, analytical data, and quality control results for APIs, drug products, and packaging to ensure compliance with GMP and regulatory standards.
Role type
QA Batch Record Specialist
Builds
Compliant pharmaceutical manufacturing records and documentation packages
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, analytical data verification, regulatory knowledge (FDA/EU), SOP development, eQMS management, variance reporting
Preferred skills
Analytical education, experience with CMOs, inspection readiness support
Technologies
eQMS (Veeva), MS Office (Word, Excel, PowerPoint)
Responsibilities
Review and verify executed batch records of APIs, drug products, primary and secondary labeling and packaging; Review and verify analytical data; Review and assess relevant quality control results against acceptable limits; Review and complete records ensuring compliance with applicable SOPs and regulatory regulations; Archive entire batch documentation in eQMS; Report variances, errors, and deviations to supervisor; Write and implement standard operating procedures and work instructions for QA processes
Seniority
Mid-level, hands-on IC