Senior Deviation Investigation Specialist

Fusion Life Science Technologies LLC; Greenville (NC); On-site; USD 96,000 - 165,000; Full time

Job summary

Fusion Life Science Technologies LLC seeks a Senior Deviation Investigation Specialist to support a pharmaceutical client in Greenville, NC, on a 3-6 month engagement.

You will investigate deviations, perform root cause analysis, develop CAPAs, review records, and draft compliant reports while coordinating with Manufacturing, Quality and Engineering to clear a large backlog.

Applicants should have 10+ years in sterile/pharma manufacturing, GMP knowledge, and strong technical writing.

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.

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.

Skills

Deviation investigations

CAPA

GMP

Quality systems

Technical writing

Cross-functional

Job description

Job Title: Senior Deviation Investigation Specialist

Location: Greenville, NC

Duration: 3-6 Months

Experience: 10+ Years

Industry: Pharmaceutical / Sterile Manufacturing

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.