Hello,
I hope youโre doing well.
My name is Vyshu, and Iโm 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:ย Deviation Writer
Location:ย Onsite - Indiana
Duration:ย 6 Months
Hours per week:ย 40 Hours per Week
Position Summary
We are seeking an experienced Deviation Writer to support Manufacturing Engineering by investigating and documenting deviations, non-conformances, and technical events in a GMP-regulated environment. The role involves collaborating with cross-functional teams to perform root cause investigations, develop corrective and preventive actions (CAPA), and ensure compliance with quality and regulatory requirements.
Key Responsibilities
- Investigate and document deviations, non-conformances, and technical events.
- Gather facts, analyze data, and work with Subject Matter Experts (SMEs) to determine root causes.
- Utilize root cause analysis tools such as 5 Whys and Fishbone (Ishikawa) diagrams.
- Develop effective corrective and preventive actions (CAPA).
- Translate complex technical information into clear, concise investigation reports.
- Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and other stakeholders.
- Review historical deviations and identify trends to drive continuous improvement.
- Maintain documentation within electronic Quality Management Systems (eQMS) and EDMS platforms.
Required Qualifications
- Bachelorโs degree in Science, Engineering, or a related technical field.
- Minimum 3 years of technical writing experience in a GMP-regulated environment (pharmaceutical, biopharmaceutical, or biotechnology preferred).
- Strong understanding of GMP manufacturing processes and regulatory requirements.
- Experience with root cause investigations and CAPA development.
- Proficiency in Microsoft Word, Excel, and electronic document management systems.
Preferred Skills
- Excellent technical writing and documentation skills.
- Strong analytical, organizational, and problem-solving abilities.
- High attention to detail and ability to work independently.
- Effective communication and collaboration with cross-functional teams.
Thanks & Regards
Vyshnavi
Recruiter
Intellectt Incย
vyshnavi.t@intellectt.com
Direct:ย 732 204 6550
Desk number: 732 412 6999 - Ext: 225