Senior Deviation Investigation Specialist

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

Job Title: Senior Deviation Investigation Specialist

Duration: 6 Months Contract

Industry: Pharmaceutical / Sterile Manufacturing

Interview: 2 Rounds Virtual

LinkedIn: Required

Job Description

• We are looking for an experienced Senior 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 8+ years of experience in pharmaceutical or sterile manufacturing environments, with strong hands-on experience managing, investigating, documenting, and closing deviation investigations.

Key Responsibilities

• Investigate and resolve manufacturing and quality deviations.
• Perform root cause analysis (RCA) and identify appropriate corrective and preventive actions (CAPA).
• 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 the client in reducing the existing 200+ deviation backlog.
• Manage multiple deviation investigations simultaneously while meeting aggressive deadlines.
• Ensure investigation documentation is complete, technically sound, and compliant with applicable quality-system requirements.

Required Qualifications

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