Deviation Investigator — GMP Quality & CAPA Leader

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA, Monroe site seeks a Deviation Investigator to own manufacturing deviations, perform root cause analyses, and implement corrective actions to close investigations on time.

Reporting to the Head of Operations and the Head of Quality Systems, the role supports aseptic manufacturing processes, coordinates cross-functional reviews, and drives quality improvements to ensure CGMP compliance.

Qualifications

• Bachelor-level degree in science/engineering/pharma.
• Minimum three years in Quality Assurance in pharma/biopharma/medical device industry or equivalent.
• Strong understanding of GMPs and FDA/ICH guidelines.

Responsibilities

• Ensure investigations are logged, triaged, investigated, and resolved by deadlines.
• Coordinate testing of samples for investigations where applicable.
• Review batch records, QC data, and quality investigations.

Skills

Root Cause Analysis

CAPA

CGMP

Quality Systems

Documentation

Training

Cross-functional Collaboration

Data Trending

Problem Solving

Regulatory Compliance

Education

BS/BA in Science or Eng

Job description

Glenmark Pharmaceuticals Inc., USA, Monroe site seeks a Deviation Investigator to own manufacturing deviations, perform root cause analyses, and implement corrective actions to close investigations on time.

Reporting to the Head of Operations and the Head of Quality Systems, the role supports aseptic manufacturing processes, coordinates cross-functional reviews, and drives quality improvements to ensure CGMP compliance.