Aseptic Quality Investigator – CGMP Deviations

Global Blockchain Talent; Monroe (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA, seeks a Pharmaceutical Manufacturing Investigator to own and investigate manufacturing deviations. You will perform root cause analyses, implement corrective actions, and collaborate with cross-functional teams to close investigations on time.

Reporting to Quality Systems and Operations leaders, you will analyze data, prepare APR materials, and drive continuous improvements to GMP compliance across aseptic manufacturing processes at the Monroe site.

Qualifications

• BS/BA in Science, Engineering, or Pharmaceutical Sciences.
• Strong understanding of current GMPs and FDA/ICH guidelines.
• Experience in quality assurance and investigations is required.

Responsibilities

• Investigate manufacturing deviations and perform root cause analyses.
• Coordinate with cross functional teams for testing and data reviews.
• Prepare data for APR submissions and track investigations.
• Ensure CGMP compliance and timely CAPA/Change Controls.
• Develop SOPs and train staff on quality processes.
• Provide routine status updates and trend reports.

Skills

GMP knowledge

Root cause analysis

Time management

Communication skills

Analytical skills

Problem solving

Team collaboration

Detail oriented

Education

Bachelor's degree in Science/Engineering

Job description

Glenmark Pharmaceuticals Inc., USA, seeks a Pharmaceutical Manufacturing Investigator to own and investigate manufacturing deviations. You will perform root cause analyses, implement corrective actions, and collaborate with cross-functional teams to close investigations on time.

Reporting to Quality Systems and Operations leaders, you will analyze data, prepare APR materials, and drive continuous improvements to GMP compliance across aseptic manufacturing processes at the Monroe site.