Calibration, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, GMP (Good Manufacturing Practices), Investigative Reports, Laboratory Analysis, Leadership, Machining, Manufacturing, Process Analysis, QA Partner Testing Software, Quality Control, Root Cause Analysis, Team Player, Technical Writing, Writing Skills
Hello,
I hope you're doing well.
My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Deviation Investigator API Manufacturing based in Rensselaer, NY, with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at
mahalakshmi.n@intellectt.com
OR +1 (732) 737 8381Role: Senior Deviation Investigator API Manufacturing
Location: Rensselaer, NY
Position Summary
Seeking an experienced Investigation Writer / Deviation Investigator to support GMP investigation backlog reduction and improve investigation closure timelines within an API manufacturing environment. This role requires strong deviation investigation, root cause analysis, technical writing, and CAPA experience.
Key Responsibilities
- Lead deviation investigations from initiation through closure.
- Author comprehensive investigation reports.
- Perform Root Cause Analysis (5 Why, Fishbone, 6M, Cause & Effect).
- Assess product, process, and batch impact.
- Define, implement, and verify CAPA effectiveness.
- Support backlog investigation remediation activities.
- Manage investigations using TrackWise/eQMS.
- Facilitate cross-functional investigation meetings.
- Partner with QA, QC, Manufacturing, Engineering, Technical Services, Maintenance, and Calibration teams.
Required Qualifications
- Hands-on experience in API Manufacturing environments.
- Proven experience leading GMP deviation investigations.
- Experience with QC investigations, including OOS, OOT, lab deviations, analytical discrepancies, and quality events.
- Shop-floor manufacturing experience.
- Strong technical writing and investigation report authoring skills.
- Experience with CAPA, RCA methodologies, and TrackWise/eQMS.
- Ability to manage multiple investigations simultaneously.
Preferred Attributes
- Self-motivated with strong ownership and accountability.
- Ability to professionally challenge stakeholders when necessary.
- Strong communication and cross-functional collaboration skills.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381