Hello,
I hope you’re doing well.
My name is Vyshu, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Deviation Writer based in Indiana 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 vyshnavi.t@intellectt.com
Position: Deviation Writer
Location: Onsite - Indiana
Duration: 6 Months
Hours per week: 40 Hours per Week
Start Date: July 6th
Summary:
We are seeking an experienced Deviation Writer to support investigation writing and root cause analysis within a GMP-regulated manufacturing environment. This role partners with Manufacturing, Engineering, MS&T, Supply Chain, and Quality teams to develop clear, data-driven deviation investigations, identify root causes, and implement effective CAPAs.
Key Responsibilities:
- Author and manage deviation investigations and technical reports.
- Conduct root cause analysis using tools such as Fishbone and 5 Whys.
- Develop corrective and preventive actions (CAPAs).
- Collaborate with cross-functional teams to gather data and support investigations.
- Ensure compliance with GMP and quality system requirements.
Requirements:
- Bachelor’s degree in Science, Engineering, or a related technical field.
- 3+ years of technical writing and deviation investigation experience in a GMP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
- Strong knowledge of GMP, CAPA, root cause analysis, and eQMS systems.
- Proficiency in Microsoft Word and Excel.
- Excellent written communication and collaboration skills.
Thanks & Regards,
Vyshnavi
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225