Quality Engineer II: Deviation & CAPA Lead

PAI Pharma; South Carolina; On-site; USD 80,000 - 110,000; Full time

Job summary

PAI Pharma in Greenville, SC seeks a Quality Engineer II to independently lead deviation investigations across manufacturing, packaging, material handling, and laboratory support. You will perform structured root cause analysis, develop CAPAs, and ensure complete, scientifically sound reports for regulatory review.

The role acts as a technical resource for operations and helps drive continuous improvement of investigation and CAPA processes with cross‑functional teams.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field.
• 3–7 years of pharmaceutical or regulated manufacturing experience.
• Experience conducting deviation investigations and performing root cause analysis.
• Experience using electronic quality systems (TrackWise strongly preferred).

Responsibilities

• Lead full lifecycle of routine and moderately complex deviation investigations.
• Assess product impact, quality risks, and systemic implications.
• Conduct structured root cause analysis and document rationale.
• Author clear investigation reports for internal and regulatory review.
• Identify, propose, and implement CAPAs tied to root causes.
• Collaborate with Manufacturing, Packaging, QC, and Facilities to validate findings.
• Perform CAPA effectiveness checks and suggest prevention-based solutions.
• Contribute to trending reports and communicate findings to management.
• Support training and mentoring of junior QE staff or Specialists.
• Participate in inspection readiness activities and audits.

Skills

Technical problem solving

Data synthesis

cGMP knowledge

Cross‑functional communication

Education

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related

Tools

TrackWise

Job description

PAI Pharma in Greenville, SC seeks a Quality Engineer II to independently lead deviation investigations across manufacturing, packaging, material handling, and laboratory support. You will perform structured root cause analysis, develop CAPAs, and ensure complete, scientifically sound reports for regulatory review.

The role acts as a technical resource for operations and helps drive continuous improvement of investigation and CAPA processes with cross‑functional teams.