Quality Assurance Specialist (Investigations)

We are seeking a Quality Assurance Specialist (Investigations) to support deviation investigations and CAPA activities within a GMP-regulated API manufacturing environment. This is a contract-to-hire opportunity with a stable and growing pharmaceutical organization

Location: St. Louis, MO (Fully Onsite)

Pay: $32–$36/hr

Type: Contract-to-Hire

Schedule: Monday – Friday: 8 hour Days

Key Responsibilities

• Lead and manage investigations related to internal deviations and customer complaints
• Perform root cause analysis and drive corrective and preventive actions (CAPAs) to closure
• Review analytical and chemical test data as part of investigations
• Conduct interviews to determine event timelines and root causes
• Track, trend, and maintain investigation and CAPA records
• Ensure timely completion and effectiveness of CAPAs
• Partner cross-functionally with QA, QC, Production, and Engineering teams
• Support audit readiness and participate in regulatory inspections
• Assist with SOP development, updates, and training
• Provide regular updates through quality meetings and reporting
  
  

Requirements

• 5–8 years of investigation experience in an FDA-regulated environment (API preferred)
• Strong experience with root cause analysis, CAPAs, and GMP compliance
• Background in pharmaceutical or chemical manufacturing
• Experience supporting regulatory audits and inspections
• Strong documentation, communication, and organizational skills
  
  

Nice to Have

• Experience in API manufacturing environments
• Familiarity with ICH guidelines and quality systems
  
  

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH