Senior Manufacturing Specialist
Core
Manage technical documentation, address non-conformances, and implement corrective actions to ensure operational efficiency and compliance in biologics manufacturing.
Role type
Senior Manufacturing Specialist (Quality & Operations)
Builds
Electronic batch records, GMP-related documents, and continuous improvement strategies for biologics production.
Domain
Biologics manufacturing / Pharmaceutical / Quality Management Systems
Required skills
Technical writing, GMP compliance, Change management, Root cause analysis, KPI analysis, Regulatory inspection preparation, Cross-functional leadership, EHS policy adherence
Preferred skills
cGMP knowledge, MES systems (Trackwise, SAP, LIMS), Training module development, GEMBA walkdowns
Technologies
Trackwise, LIMS, SAP, POMSnet, Delta-V, MES systems
Responsibilities
Author and revise GMP-related documents, Conduct investigations into non-conformance issues, Lead or participate in new product introduction projects, Prepare and support regulatory inspections, Organize cross-functional meetings for operational updates, Execute process improvement changes on schedule
Seniority
Senior, hands-on IC