Biotech and Pharmaceutical, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Collection, GMP (Good Manufacturing Practices), Investigative Reports, Maintain Compliance, Manufacturing, Microsoft Excel, Microsoft Word, Quality System Requirements (QSR), Root Cause Analysis, Supply Chain, Team Player, Technical Writing, Writing Skills
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 Indianawith 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