Senior Deviation Investigator — GMP Quality, Backlog Resolver

Fusion Life Sciences Technologies LLC; Greenville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Fusion Life Sciences Technologies LLC in Greenville, NC is seeking a Senior Deviation Investigation Specialist to support a pharmaceutical manufacturing client with a large backlog of deviations. You will investigate, document, and close deviations to GMP standards by year end.

You will conduct root cause analysis, develop CAPAs, review records, and prepare clear investigation reports while coordinating with Manufacturing, Quality, and Engineering to meet aggressive timelines.

Qualifications

• 8+ years of relevant pharmaceutical, biotechnology, or regulated manufacturing experience.
• Strong hands-on experience with deviation investigations and resolution.
• Strong background in sterile and/or pharmaceutical manufacturing environments.
• Demonstrated experience performing root cause analysis (RCA).
• Experience developing and implementing CAPA.
• Strong knowledge of GMP requirements and pharmaceutical quality systems.

Responsibilities

• Investigate and resolve manufacturing and quality deviations.
• Perform root cause analysis (RCA) and identify appropriate CAPAs.
• Review manufacturing, batch, and quality records to support deviation investigations.
• Prepare clear, accurate, and GMP-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 backlog reduction for the deviation backlog.
• Manage multiple investigations simultaneously while meeting deadlines.
• Ensure investigation documentation is complete, technically sound, and compliant with quality systems.

Skills

Root cause analysis (RCA)

CAPA development

GMP knowledge

Cross-functional collaboration

Project management

Job description

Fusion Life Sciences Technologies LLC in Greenville, NC is seeking a Senior Deviation Investigation Specialist to support a pharmaceutical manufacturing client with a large backlog of deviations. You will investigate, document, and close deviations to GMP standards by year end.

You will conduct root cause analysis, develop CAPAs, review records, and prepare clear investigation reports while coordinating with Manufacturing, Quality, and Engineering to meet aggressive timelines.