Compliance Specialist
Core
Subject matter expert for change controls and nonconformances, overseeing shelf-life extensions, NPIs, terminations, equipment introductions, and specification updates in a regulated environment.
Role type
Compliance Specialist (Regulatory/Quality)
Builds
Process improvements and documentation compliance for a biotechnology client
Domain
Life Sciences / Biotechnology / GMP
Deliverable
Dashboards & analysis | client delivery
Required skills
Change control management, Analytical data interpretation, Documentation review and approval, Process optimization, Regulatory compliance knowledge, Scientific qualification
Preferred skills
GMP experience, COMET system familiarity
Technologies
COMET system
Responsibilities
Oversee change controls and nonconformances, Interpret analytical data with scientific rigour, Drive process improvements, Present technical data to stakeholders, Collaborate across teams to maintain SOP alignment, Review and approve documentation
Seniority
Individual Contributor