Technical Writer

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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