Quality Engineer II: Deviation & CAPA Investigator

PAI Pharma; Greenville (SC); Presencial; USD 85.000 - 110.000; Tempo integral

Resumo da vaga

PAI Pharma in Greenville, SC seeks a Quality Engineer II to independently lead deviation investigations across manufacturing, packaging, and lab support, ensuring reports are complete, scientifically sound, and compliant.

The role requires 3–7 years in pharmaceutical manufacturing, a Bachelor's in Life Sciences, Chemistry, or Engineering, and experience with CAPAs and TrackWise. Strong problem-solving and cross-functional collaboration are essential.

Qualificações

• Strong technical problem-solving skills.
• Ability to synthesize data and clearly articulate investigation conclusions.
• Strong understanding of cGMP, documentation practices, and regulatory expectations.
• Effective facilitation and communication skills across multiple departments.

Responsabilidades

• Lead full lifecycle of routine and moderately complex deviation investigations.
• Perform thorough assessment of potential product impact, quality risks, and systemic implications.
• Conduct structured root cause analysis and document rationale for conclusions.
• Author clear, complete, and well-supported investigation reports suitable for internal and regulatory review.
• Identify, propose, and implement effective CAPAs tied directly to identified root causes.
• Collaborate with Manufacturing, Packaging, QC, and Facilities to validate findings and ensure implementation feasibility.
• Perform CAPA effectiveness checks and identify opportunities for 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 present investigations during audits.

Conhecimentos

Technical problem-solving

Data synthesis

cGMP knowledge

Regulatory documentation

Cross-functional communication

Formação

Bachelor’s degree in Life Sciences/ Chemistry/ Engineering

Ferramentas

TrackWise

Descrição da vaga

PAI Pharma in Greenville, SC seeks a Quality Engineer II to independently lead deviation investigations across manufacturing, packaging, and lab support, ensuring reports are complete, scientifically sound, and compliant.

The role requires 3–7 years in pharmaceutical manufacturing, a Bachelor's in Life Sciences, Chemistry, or Engineering, and experience with CAPAs and TrackWise. Strong problem-solving and cross-functional collaboration are essential.