Compliance Investigation Specialist I
On-site · Brentwood, Missouri, United States
Job Summary
The incumbent will provide guidance, coaching and coordination for the initiation, tracking, trending and management of Manufacturing Investigation Reports (MIR), Corrective and Preventive Actions (CAPA), evaluation of CAPA effectiveness and Operational Excellence (OPEX) projects within Sterile Product Manufacturing (SPM) operations. Facilitates completion of MIRs and CAPA analyses to ensure quality/system compliance; analyzes historical data to identify root causes of deviations; develops and implements corrective/preventive actions; ensures QAR system requirements M1/PHP are executed per SOPs; acts as primary contact for MIR resolution; collaborates on trainings to educate employees on reporting, initiating and closing investigations; leads OPEX-focused process improvements to enhance quality, efficiency and safety.
Required Qualifications
- BA/BS/MS in Engineering, Chemistry, Physical/Biological Sciences, Business, Integrated Supply Management, or related discipline
- Minimum nine years of applicable experience
- Lean Six Sigma education and experience
- Green/Black belt certification highly desired
- Strong GMP Manufacturing, QA/QC, Aseptic Manufacturing and/or Environmental Monitoring background
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