Quality Engineer II: Deviation & CAPA Lead

PAI Pharma; Greenville (SC); On-site; USD 75,000 - 110,000; Full time

Job summary

PAI Pharma in Greenville, SC is seeking a Quality Engineer II to lead deviation investigations, perform root cause analyses, and drive CAPA programs to maintain compliant manufacturing, packaging, and lab support processes.

The role collaborates with Manufacturing, Packaging, QC, and Facilities, and supports audits and training of junior QE staff while ensuring investigations are complete, well‑documented, and scientifically sound.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field required.
• 3–7 years of pharmaceutical or regulated manufacturing experience.
• Demonstrated 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 for conclusions.
• Author clear, complete investigation reports for internal and regulatory review.
• Identify and implement CAPAs tied to identified root causes.
• Collaborate with Manufacturing, Packaging, QC, and Facilities to validate findings and feasibility.
• Perform CAPA effectiveness checks and prevention opportunities.
• Support trending reports and communicate findings to management.
• Assist in training and mentoring junior QE staff or Specialists.
• Participate in inspection readiness and present investigations during audits.

Skills

Deviation investigations

Root cause analysis

CAPA implementation

cGMP knowledge

Regulatory knowledge

Education

Bachelor’s degree in Life Sciences

Tools

TrackWise

Job description

PAI Pharma in Greenville, SC is seeking a Quality Engineer II to lead deviation investigations, perform root cause analyses, and drive CAPA programs to maintain compliant manufacturing, packaging, and lab support processes.

The role collaborates with Manufacturing, Packaging, QC, and Facilities, and supports audits and training of junior QE staff while ensuring investigations are complete, well‑documented, and scientifically sound.