GMP Quality Investigator & CAPA Leader

Stark Pharma Solutions Inc; Indianapolis (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking an experienced Investigation Specialist to support quality investigations within a GMP-regulated pharmaceutical manufacturing environment. The role focuses on root cause analysis, documenting investigations, and implementing effective CAPA.

You will lead deviation and non-conformance investigations, review manufacturing events, develop corrective actions, and ensure compliance with GMP and FDA requirements while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences.
• Experience in pharmaceutical/biotech manufacturing or quality.
• Experience with GMP, deviations, investigations, RCA, and CAPA.
• Experience with electronic quality management systems (eQMS) preferred.

Responsibilities

• Lead and support deviation, non-conformance, and quality investigations.
• Perform Root Cause Analysis (RCA) using 5-Why, Fishbone, and other methodologies.
• Review manufacturing, laboratory, equipment, and process-related events.
• Develop and implement CAPA and effectiveness checks.
• Prepare clear investigation reports and supporting documentation.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and other teams.
• Ensure investigations comply with GMP, FDA, and company quality requirements.
• Maintain accurate investigation and quality documentation.

Skills

Root Cause Analysis

CAPA

GMP Knowledge

Documentation

Cross-functional Collaboration

Analytical Thinking

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences

Tools

eQMS

Job description

Stark Pharma Solutions Inc is seeking an experienced Investigation Specialist to support quality investigations within a GMP-regulated pharmaceutical manufacturing environment. The role focuses on root cause analysis, documenting investigations, and implementing effective CAPA.

You will lead deviation and non-conformance investigations, review manufacturing events, develop corrective actions, and ensure compliance with GMP and FDA requirements while collaborating with cross-functional teams.