Compliance Specialist III
Core
Lead investigations and compliance activities to ensure adherence to regulatory standards in a pharmaceutical manufacturing environment.
Role type
Senior IC compliance specialist (pharmaceutical manufacturing)
Builds
Compliance documentation, deviation reports, and root cause analysis for cGMP operations
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Required skills
Root cause analysis, cross-functional team leadership, cGMP operations knowledge, technical report review, batch record management, SOP development, regulatory guidance adherence, manufacturing documentation maintenance, training compliance
Preferred skills
None stated
Technologies
Microsoft Word, Microsoft Excel, Fishbone diagrams, 5-Why's
Responsibilities
Lead deviation and investigations using root cause analysis methods, lead cross-functional teams to address compliance gaps, monitor compliance trends, assist with review of technical reports supporting cGMP operations, collaborate with cGMP business units to resolve record inconsistencies, recommend batch record changes for continuous improvement, assist in writing Standard Equipment Procedures and Standard Instrument Procedures, maintain high-quality manufacturing documentation, participate in assigned improvement projects, maintain compliance with all assigned training requirements
Seniority
Mid-Senior level, hands-on IC
