Operations Production Specialist
Core
Ensure manufacturing operations run safely, efficiently, and in compliance with GMP standards to support production readiness and deliver life-changing therapies.
Role type
Operations Production Specialist (GMP Manufacturing)
Builds
Medicines and life sciences therapies
Domain
Life Sciences / Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record management, data integrity, electronic batch records, quality system support, investigation support, continuous improvement methodologies
Preferred skills
Project management tools, Lean manufacturing, biotechnology/pharmaceutical/medical device industry experience
Technologies
Electronic batch records systems, project management tools
Responsibilities
Manage batch records, forms, logbooks, and controlled manufacturing documents; Review completed batch records and electronic data for accuracy and completeness; Support GMP compliance activities, investigations, and corrective actions; Maintain inspection readiness and support internal/external audits; Lead or contribute to continuous improvement and Lean manufacturing initiatives; Partner with Operations, Quality, and MSAT teams to improve site performance.
Seniority
Individual Contributor, mid-level operational role
