Manufacturing Quality Investigator & CAPA Lead

Nephron Pharmaceuticals Corporation; West Columbia (SC); In loco; USD 75.000 - 110.000; Tempo pieno

Descrizione del lavoro

Nephron Pharmaceuticals Corporation in West Columbia, SC is seeking a Manufacturing Process Investigator to drive root cause analyses for deviations and quality concerns. You will collaborate with production and quality teams to implement CAPA plans, draft SOPs, and ensure compliance with FDA and GMP guidelines in a fast-paced manufacturing environment.

This role emphasizes technical writing, data analysis, and continuous improvement using Lean and Six Sigma methodologies to prevent recurrence

Competenze

• 3+ years of experience in a QA, technical writing, or investigation role in a BFS/pharma manufacturing environment.
• Certifications in Lean, Six Sigma, or similar continuous improvement methodologies are a plus.
• Strong background in SOP writing, CAPA management, investigation writing, and procedural updates.
• Working knowledge of regulatory requirements (FDA, EU GMP) and industry best practices is a plus.

Mansioni

• Conduct root cause analyses for deviations, product complaints, and quality incidents.
• Prepare thorough investigation reports with accuracy and regulatory compliance.
• Develop and maintain CAPA plans with input from operators, SMEs, and management.
• Draft, review, and update SOPs to align with regulatory requirements and internal standards.
• Collaborate with production and quality teams to implement corrective and preventive actions.
• Track CAPA action items and assess their effectiveness.
• Provide training on updated SOPs, CAPAs, and procedural changes.

Conoscenze

Technical writing

Analytical thinking

Root cause analysis

Communication

Team collaboration

Formazione

Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field

Lean Six Sigma certification (plus)

Strumenti

Quality management software

Microsoft Office Suite

Descrizione del lavoro

Nephron Pharmaceuticals Corporation in West Columbia, SC is seeking a Manufacturing Process Investigator to drive root cause analyses for deviations and quality concerns. You will collaborate with production and quality teams to implement CAPA plans, draft SOPs, and ensure compliance with FDA and GMP guidelines in a fast-paced manufacturing environment.

This role emphasizes technical writing, data analysis, and continuous improvement using Lean and Six Sigma methodologies to prevent recurrence