Quality Process Investigator - RCA, CAPA & SOPs

NEPHRON SC, LLC; West Columbia (SC); On-site; USD 70,000 - 100,000; Full time

Job summary

NEPHRON SC, LLC in West Columbia, SC is seeking a Manufacturing Process Investigator to lead investigations into deviations, non-conformances, and quality concerns. You will identify root causes and drive CAPA actions while working with production and quality teams to document findings and support continuous improvement.

Candidates should have a Bachelor’s degree in Engineering or Life Sciences, at least 3 years in QA/investigation, and knowledge of FDA/GMP standards.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or a related field preferred.
• Certifications in Lean, Six Sigma, or similar continuous improvement methodologies are a plus.
• 3 years of experience in a Quality Assurance, Technical Writing, or Investigation role, preferably in a BFS or pharmaceutical manufacturing environment.
• Strong background in SOP writing, CAPA management, investigation writing, and procedural updates.

Responsibilities

• Investigate deviations, non-conformances, and quality concerns and identify root causes.
• Develop and track CAPA plans with input from operators, SMEs and management.
• Prepare thorough investigation reports ensuring accuracy and regulatory compliance.
• Collaborate with production and quality teams to implement corrective and preventive actions.
• Draft, review, and update SOPs to align with regulatory requirements.

Skills

Technical writing

Analytical thinking

Root cause analysis

Communication skills

Problem solving

Education

Bachelor’s degree in Engineering/Life Sciences/Pharmacy

Lean, Six Sigma certifications

3 years QA/investigation experience

FDA/EU GMP knowledge

Tools

Microsoft Office Suite

Quality management software

Job description

NEPHRON SC, LLC in West Columbia, SC is seeking a Manufacturing Process Investigator to lead investigations into deviations, non-conformances, and quality concerns. You will identify root causes and drive CAPA actions while working with production and quality teams to document findings and support continuous improvement.

Candidates should have a Bachelor’s degree in Engineering or Life Sciences, at least 3 years in QA/investigation, and knowledge of FDA/GMP standards.