GMP Deviation Investigator & CAPA Lead

ACTalent; Greenville (NC); On-site; USD 57,000 - 81,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

HSA

Job summary

Actalent in Greenville, NC seeks a Deviation Investigator to identify, document, investigate and resolve deviations from SOPs, GMP and regulatory requirements. You will develop CAPAs, track actions, and contribute to improvements across quality systems.

The role emphasizes root-cause analysis, technical writing, and collaboration with cross-functional teams, with focus on aseptic environments and GDP-compliant documentation.

Qualifications

• Experience performing GMP investigations.
• Strong root-cause analysis skills (fishbone, 5 Whys).
• Experience writing compliant investigation reports.

Responsibilities

• Identify and document deviations from SOPs and regulations.
• Conduct structured investigations and determine root causes.
• Develop CAPAs with cross-functional teams and track progress.
• Ensure CAPA effectiveness and on-schedule closure.
• Maintain GDP-compliant records of deviations, investigations, CAPAs.
• Prepare investigation reports for internal/regulatory review.
• Present findings and CAPA status to stakeholders.
• Support audits and inspections with documentation.

Skills

GMP knowledge

Root cause analysis

CAPA development

Technical writing

Aseptic environment

Cross-functional collaboration

GDP documentation

Education

Bachelor's degree in a scientific field

Tools

Documentation systems

Job description

Actalent in Greenville, NC seeks a Deviation Investigator to identify, document, investigate and resolve deviations from SOPs, GMP and regulatory requirements. You will develop CAPAs, track actions, and contribute to improvements across quality systems.

The role emphasizes root-cause analysis, technical writing, and collaboration with cross-functional teams, with focus on aseptic environments and GDP-compliant documentation.