Deviation Writer

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.

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