Manufacturing Quality Process Investigator

Nephron Pharmaceuticals Corporation; Columbia (SC); Presencial; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

Nephron Pharmaceuticals Corporation is seeking a Manufacturing Process Investigator to lead investigations into deviations and quality concerns within our aseptic manufacturing environment in Columbia, SC. You will identify root causes, implement CAPAs, and drive continuous improvement across production and quality teams.

The role requires strong technical writing, knowledge of GMP/cGMP, and the ability to develop SOPs and training materials for staff while ensuring regulatory compliance and

Formación

• Bachelor's degree in Engineering, Life Sciences, Pharmacy or related field.
• 3+ years of experience in Quality Assurance, Technical Writing, or Investigation role in BFS/pharmaceutical manufacturing.
• Certifications in Lean Six Sigma or similar continuous improvement methodologies a plus.
• Strong background in SOP writing, CAPA management, investigation writing, and procedural updates.
• Working knowledge of FDA, EU GMP and industry best practices.

Responsabilidades

• Investigate deviations, non-conformances, and quality concerns with root cause analysis.
• Prepare thorough investigation reports ensuring accuracy and regulatory compliance.
• Collaborate with production and quality teams to implement CAPAs and preventive actions.
• Develop and maintain technical documentation to support manufacturing and quality processes.
• Draft, review and update SOPs to ensure alignment with regulatory requirements.
• Provide training on new or updated SOPs, CAPAs and procedural changes.
• Ensure compliance with cGMPs, safety guidelines and internal quality policies.

Conocimientos

Technical writing

Analytical thinking

Root cause analysis

Cross-functional collaboration

Communication skills

Educación

Bachelor's degree in Engineering, Life Sciences, Pharmacy

Lean Six Sigma certification

Herramientas

Microsoft Office Suite

Quality management software

Descripción del empleo

Nephron Pharmaceuticals Corporation is seeking a Manufacturing Process Investigator to lead investigations into deviations and quality concerns within our aseptic manufacturing environment in Columbia, SC. You will identify root causes, implement CAPAs, and drive continuous improvement across production and quality teams.

The role requires strong technical writing, knowledge of GMP/cGMP, and the ability to develop SOPs and training materials for staff while ensuring regulatory compliance and