Operations Batch Review Specialist

S4 Analytics is a growing consulting and workforce solutions firm headquartered in Texas and New Jersey, specializing in connecting highly skilled professionals with leading organizations across the Life Sciences, Semiconductor, Automotive, Defense, Data Center, and IT industries. We are committed to building long-term partnerships by delivering top talent and customized staffing solutions that support our clients’ evolving business and project needs.

We are seeking an experienced Operations Batch Review Specialist to support GMP pharmaceutical manufacturing operations by reviewing executed batch records and ensuring compliance with cGMP, SOP, and regulatory requirements. The ideal candidate will have experience with parenteral manufacturing processes, batch record review, deviation investigations, CAPA support, and quality documentation. This role requires close collaboration with Manufacturing, Quality, and Quality Systems teams to drive documentation accuracy, compliance, and continuous improvement initiatives.

• Experience with full batch documentation review in GMP manufacturing environments.
• Experience reviewing parenteral manufacturing batch records related to Formulation, Filling, Inspection, and Packaging.
• Ability to identify documentation corrections and deviations.
• Experience supporting deviation investigations and CAPA activities.
• Experience coaching operators and supervisors on documentation practices and compliance requirements.
• Ability to manage batch record review priorities within production timelines.
• Strong knowledge of cGMP regulations and manufacturing compliance requirements.
• Understanding of process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Experience working with eDMS, SCADA, BMS, CMMS, LIMS, and laboratory instrument software.
• Proficiency with Microsoft Word, Excel, and Visio.
• Experience using JMP and Minitab for data analysis and reporting.
• Experience working within Quality Management Systems (QMS).
• Experience performing Quality Control review activities.
• Knowledge of Certificate of Analysis (CoA) review and results management.
• Understanding of product disposition processes and associated quality requirements.

• Experience as performer or reviewer in Quality Management Systems
• Experience with assessment and review of Quality Control testing, CoA, and results management preferred.
• Knowledge of regulations and quality processes involving product disposition.