Job Description

Technical Writer Deviations & Change Control

Our client, a pharmaceutical manufacturing company, is seeking a detail-oriented Technical Writer with expertise in deviations and change control documentation . This onsite role plays a critical part in ensuring regulatory compliance and supporting quality operations through precise, timely, and accurate technical documentation.

Key Responsibilities

• Write, edit, and review high-quality technical documents including deviations, change controls, CAPAs , and other GMP-related records.
• Collaborate with cross-functional teams (QA, Manufacturing, Engineering, etc.) to gather accurate and complete information.
• Ensure all documentation complies with FDA, EU, and internal GMP guidelines.
• Translate complex technical information into clear, concise, and well-structured documents.
• Assist in audit readiness by maintaining organized, traceable documentation.
• Support investigations and root cause analyses by drafting clear summaries and conclusions.

Qualifications

• Bachelors degree in Life Sciences, Engineering, or a related field.
• 5+ years of experience in technical writing within the pharmaceutical or biotech industry .
• Strong knowledge of GMP , deviation management , and change control processes .
• Excellent writing, editing, and communication skills.
• Proficient with Microsoft Office Suite; experience with TrackWise or other QMS platforms a plus.
• Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment.

Applicants must be authorized to work in the United States. Sponsorship is not available for this position.

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