Manufacturing Specialist
Core
Investigate manufacturing deviations in clinical supply organizations (Drug Substance, Drug Product, Assembly/Packaging, QC, Warehouse) to determine root cause and develop corrective/preventative actions (CAPAs) aligned with regulatory requirements.
Role type
Manufacturing Specialist (Quality/Compliance)
Builds
Clinical supply chain for biopharmaceuticals
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
Root cause analysis, CAPA development, regulatory compliance, cross-functional collaboration, technical writing, audit defense
Preferred skills
Project management, leading complex investigations, biotech/pharma industry experience, science or engineering degree
Technologies
None stated
Responsibilities
Manage deviation investigations and assemble investigation teams; Drive improvements to the investigation process; Defend investigations to regulatory inspectors and internal auditors; Present complex topics to various company levels
Seniority
Specialist, individual contributor