Deviation Investigator (Sterile Fill Finish Manufacturing)
QvalFocus Inc.
Overview
We are seeking an experienced Deviation Investigator with hands-on experience in Sterile Fill Finish Manufacturing environments to support backlog investigation remediation activities within a GMP manufacturing facility.
This is a hands-on operational role requiring strong manufacturing floor investigation experience.
Responsibilities
- Lead deviation investigations through closure
- Perform RCA using 5 Why, Fishbone, 6M, and Cause & Effect Analysis
- Author clear GMP investigation reports
- Support CAPA implementation and effectiveness monitoring
- Work closely with Manufacturing, QA, QC, and technical teams
- Support sterile manufacturing troubleshooting activities
- Update SOPs and GMP documentation as needed
Required Qualifications:
- Hands-on Sterile Fill Finish Manufacturing experience
- GMP deviation investigation experience
- Strong RCA and technical documentation skills
- Experience with CAPA activities
- Manufacturing/shop floor support experience
Preferred
- Aseptic manufacturing experience
- Quality Operations or QC Lab experience
- Batch investigation and backlog remediation experience
Vacancy posted 1 day ago
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