Senior Associate Manufacturing
Core
Investigate manufacturing deviations, determine root causes, and develop corrective/preventative actions (CAPAs) for Drug Substance and Drug Product manufacturing, Supply Chain, Assembly/Packaging, Quality Control, and Warehouse Operations.
Role type
Senior Associate Manufacturing (Quality/Compliance)
Builds
Compliant manufacturing processes and regulatory documentation
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
Senior, hands-on IC