Operations Specialist
Core
Ensure cGMP compliance and safe, cost-effective processing of customer orders through real-time batch record review, equipment validation, and production floor audits.
Role type
Operations Specialist (Pharmaceutical Manufacturing)
Builds
Pharmaceutical and medical device products for biopharma companies and patients
Domain
Biopharmaceuticals / Medical Devices / cGMP Manufacturing
Required skills
cGMP compliance, batch record review, equipment calibration, 5S compliance, root cause analysis, quality event reporting, JDE label creation, safety auditing, inventory verification
Preferred skills
Packaging experience, Pharmaceutical/Bio-Pharmaceutical background, Medical Device background
Technologies
MS Office, Lotus Notes, ERP systems, JDE
Responsibilities
Perform operational production room approvals, verify first piece inspections, audit production room documentation and logbooks, review batch records and sampling pages, confirm package functionality, audit personnel safety compliance, support Root Cause Analysis, create JDE labels
Seniority
Mid-level, hands-on IC
