Lead QA Investigator

Join our team as Lead
Quality Assurance Investigator II and take the lead in driving complex investigations and CAPAs in a dynamic, FDA-regulated API manufacturing environment. Leverage your expertise in root cause analysis, GMP compliance, and audit readiness to ensure product quality and regulatory excellence while collaborating across functions to make an impact every day.

Pay
: $70k-$75k

Schedule
: 1st shift M-F

Type of Job
:
Contract to Permanent

Location
:
St. Louis, MO

At this time, Astrix cannot transfer nor sponsor a work Visa for this position.

Relocation assistance is not available for this position.

Benefits Offered:

• Medical/dental coverage!
• Weekly pay!
• 401k and PTO after 6 months!
• Great benefit package offered upon conversion!

• Lead and manage complex investigations into internal failures and external customer complaints, ensuring thorough root cause analysis.
• Drive timely completion of corrective and preventive actions (CAPAs) and verify their effectiveness.
• Collaborate cross-functionally with Production, QA, Engineering, and other departments to resolve quality issues.
• Develop and maintain investigation SOPs, work instructions, and associated training materials.
• Prepare and present investigation status updates, trend analyses, and audit-ready documentation.

• Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, or related field.
• 5–8 years of direct experience in investigations, root cause analysis, and CAPA management in an FDA-regulated API environment.
• Strong knowledge of GMP regulations, ICH Q7A standards, and quality compliance practices.
• Experience with regulatory audits and maintaining audit-ready documentation.

We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!