Deviation & CAPA Investigator (GMP Quality)

Actalent; Wilson (NC); On-site; USD 57,000 - 81,000; Full time

Benefits offered by this job

Medical, dental & vision

Critical Illness, Accident, and Hosp

401(k) Retirement Plan

Pre-tax and Roth post-tax concessions

Life Insurance (Voluntary Life & AD&D)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave

Job summary

Actalent is seeking a Deviation Investigator in Wilson, NC to identify, document, investigate, and resolve deviations in a GMP-regulated pharmaceutical environment. You will lead root-cause analyses, develop CAPAs, and track actions, ensuring documentation and reporting meet GDP standards.

The role is a 12-month contract with potential conversion to a permanent position, requiring collaboration with cross-functional teams, preparation of investigation reports, and presentation of findings to

Qualifications

• At least 2 years of experience in pharmaceutical GMP investigations.
• Strong knowledge of GMP principles and their application to deviation management and quality systems.
• Proven proficiency in root cause analysis (fishbone, 5 Whys).
• Experience writing clear, compliant investigation reports.
• Experience conducting investigations in aseptic environments, including isolator lines.

Responsibilities

• Identify and document deviations from SOPs, quality standards, and regulations.
• Conduct structured investigations to determine root causes.
• Develop robust CAPAs with cross-functional teams.
• Implement and track CAPAs, ensuring timely completion and effectiveness verification.
• Maintain GDP-compliant records of deviations, investigations, and CAPAs.
• Prepare investigation reports for internal review and regulatory inspection.
• Present deviation findings and CAPA status to stakeholders and regulators when required.
• Ensure activities align with GMP and GDP, and regulatory requirements.
• Support audits and inspections with complete documentation.
• Analyze deviation trends to identify systemic issues and process improvements.
• Contribute to continuous improvement of quality systems.

Skills

GMP knowledge

Root cause analysis

Technical writing

Aseptic environment

Cross-functional collaboration

Job description

Actalent is seeking a Deviation Investigator in Wilson, NC to identify, document, investigate, and resolve deviations in a GMP-regulated pharmaceutical environment. You will lead root-cause analyses, develop CAPAs, and track actions, ensuring documentation and reporting meet GDP standards.

The role is a 12-month contract with potential conversion to a permanent position, requiring collaboration with cross-functional teams, preparation of investigation reports, and presentation of findings to