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Deviation Investigator (API Manufacturing)

Job

QvalFocus Inc.

West Sand Lake, NY (In Person)

Full-Time

Posted 1 week ago (Updated 2 days ago) • Actively hiring

Expires 7/3/2026

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Job Description

Deviation Investigator (API Manufacturing) at QvalFocus Inc. Deviation Investigator (API Manufacturing) at QvalFocus Inc. in West Sand Lake, New York Posted in 3 days ago.
Type:
full-time
Job Description:
Overview We are seeking an experienced Deviation Investigator with strong hands-on experience in API Manufacturing environments to support backlog investigation and remediation activities within a GMP-regulated manufacturing facility. This is a hands-on shop floor support role requiring direct investigation experience within manufacturing operations. Responsibilities Lead deviation investigations from initiation to closure Perform root cause analysis using tools such as 5 Why, Fishbone, 6M, and Cause & Effect Analysis Write GMP-compliant investigation reports Support CAPA implementation and effectiveness checks Collaborate with Manufacturing, QA, QC, and technical teams Support process troubleshooting and backlog remediation activities Update SOPs and GMP documentation as required Required Qualifications Hands-on API Manufacturing experience Experience performing deviation investigations in GMP environments Strong root cause analysis and technical writing skills Experience with CAPA activities Direct manufacturing/shop floor support experience Preferred Quality Operations or QC Lab experience Batch investigation experience Backlog remediation experience