QA Investigation Writer

Intellectt INCGreenville, NC

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Overview

Remote

On-site

Job Description

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 QA Investigation Writer based Greenville, NC | Onsite , at 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 8381Job Title: QA Investigation WriterLocation: Greenville, NC

Seeking a QA professional with strong hands-on experience writing investigation reports in pharmaceutical or biotechnology GMP environments.

Responsibilities:

Author clear, thorough deviation, OOS/OOT, and manufacturing investigation reports.
Conduct root-cause analysis using tools such as 5 Whys and Fishbone.
Document product-impact assessments, develop CAPAs, and support timely investigation closure.
Collaborate with Manufacturing, QC, Engineering, and QA to gather evidence and ensure inspection-ready documentation.

Requirements:

Proven experience independently writing and closing GMP investigations.
Strong technical writing, analytical, and communication skills.
Experience with TrackWise, Veeva, or similar quality systems preferred.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

• Thanks & Regards,• Mahalakshmi• Junior Recruiter• Intellectt Inc

mahalakshmi.n@intellectt.com

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