Astrix · 1 day ago
Lead QA Investigator
St Louis, MO
Full-time
Onsite
Mid, Senior Level
$70K/yr - $75K/yr
5+ years expAstrix is seeking a Lead Quality Assurance Investigator II to drive complex investigations and CAPAs in an FDA-regulated API manufacturing environment. The role involves ensuring product quality and regulatory excellence through root cause analysis, GMP compliance, and collaboration across functions.
ConsultingInformation Technology
No H1B
Hiring Manager
Nichole McGowan
Responsibilities
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
Qualification
Required
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
Benefits
Medical/dental coverage!
Weekly pay!
401k and PTO after 6 months!
Great benefit package offered upon conversion!
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
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