Site Deviation Investigator
Core
Lead investigations into manufacturing deviations to identify root causes, implement corrective and preventive actions, and ensure compliance with Good Manufacturing Practices for gummy production.
Role type
Site Deviation Investigator
Builds
Consumer health gummy products (gelatin and plant-based) for nutritional supplements and nutraceutical applications
Domain
Pharmaceutical manufacturing / Consumer health / Nutraceuticals
Deliverable
client delivery
Required skills
Root cause analysis, Corrective and preventive action (CAPA) design, Risk management, Technical writing, Regulatory standards knowledge (21 CFR, ISO), Data assessment, Cross-functional collaboration
Preferred skills
Processing or batching manufacturing experience, Statistical tools application
Technologies
TrackWise, Microsoft Office (Word, Excel, 365 Copilot)
Responsibilities
Gather information to evaluate deviation impact, Assess historical manufacturing and laboratory data, Design corrective and preventive actions, Lead revision or development of Standard Operating Procedures, Present completed investigations to site leadership, Drive continuous improvement in manufacturing operations
Seniority
Mid-level, hands-on IC
