Deviation Investigator: CAPA & GMP Quality Expert

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

Benefits offered by this job

Medical, dental & vision

401(k) Plan

Life Insurance

Disability insurance

Health Spending Account

Transportation benefits

Employee Assistance Program

PTO & Vacation

Job summary

Actalent is seeking a Deviation Investigator in Greenville, NC to identify, document, investigate, and resolve deviations from SOPs and regulatory standards within a GMP environment. The role emphasizes CAPA development, trend analysis, and cross-functional collaboration to prevent recurrence.

Responsibilities include conducting root-cause investigations, ensuring GDP-compliant records, and presenting findings to stakeholders and regulators.

Qualifications

• 2+ years in pharmaceutical investigations under GMP
• Strong GMP principles in deviation management and GDP
• Proven root cause analysis with fishbone/5 Whys
• Clear, compliant investigation reports writing
• Experience in aseptic environments and isolator lines
• Detail-oriented documentation aligned with GDP
• Collaborative with cross-functional teams during investigations

Responsibilities

• Identify and document deviations from SOPs and regulatory guidelines.
• Conduct structured investigations to determine root causes.
• Develop and implement CAPAs with cross-functional teams.
• Track CAPAs for timely completion and effectiveness verification.
• Maintain compliant records per GDP.
• Prepare written investigation reports for internal/regulatory review.
• Present findings and CAPA status to stakeholders.
• Ensure deviation activities align with GMP and regulatory requirements.
• Participate in audits and inspections providing documentation.
• Analyze deviation trends for process improvements.
• Support continuous improvement of quality systems.
• Participate in training on deviation management and QA.
• Conduct investigations in aseptic environments including isolator lines.
• Support process improvements based on deviation insights.

Skills

GMP knowledge

Root cause analysis

CAPA development

Technical writing

Investigations in GMP

Aseptic environment

Documentation practices

Cross-functional collaboration

Job description

Actalent is seeking a Deviation Investigator in Greenville, NC to identify, document, investigate, and resolve deviations from SOPs and regulatory standards within a GMP environment. The role emphasizes CAPA development, trend analysis, and cross-functional collaboration to prevent recurrence.

Responsibilities include conducting root-cause investigations, ensuring GDP-compliant records, and presenting findings to stakeholders and regulators.