Fusion Life Science Technologies LLC
Senior Deviation Investigation Specialist
Greenville, North Carolina•Contract
$55 - $60 hourly
$55 - $60 hourly
About the Job
Job Title: Senior Deviation Investigation Specialist
Location: Greenville, NC
Location: Greenville, NC
Duration: 3-6 Months
Experience: 10+ Years
Industry: Pharmaceutical / Sterile Manufacturing
Industry: Pharmaceutical / Sterile Manufacturing
Job Description:
We are looking for an experienced Deviation Investigation Specialist to support a pharmaceutical manufacturing client in Greenville, NC. The client currently has a significant backlog of 200+ deviations that need to be investigated, documented, and resolved by the end of the year.
The ideal candidate will have 10+ years of experience in pharmaceutical or sterile manufacturing environments, with strong hands-on experience managing and closing deviation investigations.
Key Responsibilities:
- Investigate and resolve manufacturing and quality deviations.
- Perform root cause analysis and identify appropriate corrective and preventive actions (CAPA).
- Review manufacturing, batch, and quality records to support investigations.
- Prepare clear and compliant deviation investigation reports.
- Work closely with Manufacturing, Quality, Engineering, and other cross-functional teams.
- Ensure deviations are investigated and closed within required timelines.
- Support the client in reducing the existing deviation backlog.
Required Qualifications:
- 10+ years of relevant industry experience.
- Strong experience with deviation investigations and resolution.
- Background in sterile manufacturing and/or pharmaceutical manufacturing environments.
- Experience with root cause analysis and CAPA.
- Strong knowledge of GMP and quality systems.
- Excellent technical writing, documentation, and communication skills.
- Ability to manage multiple investigations and work toward aggressive deadlines.
Preferred:
Experience working in a high-volume pharmaceutical/sterile manufacturing environment with a proven track record of successfully reducing deviation backlogs.
Experience working in a high-volume pharmaceutical/sterile manufacturing environment with a proven track record of successfully reducing deviation backlogs.