Technical Writer

Position Summary

The Technical Writer is responsible for authoring, reviewing, and maintaining high-quality GMP documentation, including master and executed batch records, SOPs, protocols, reports, and related technical documents. This role ensures compliance with FDA, EU, and ICH regulatory requirements and works cross-functionally with Manufacturing, Quality, Engineering, and Project Management to translate process knowledge into clear, accurate, and compliant documentation.

Key Responsibilities

Document Creation & Management

• Author, revise, and maintain Master Batch Records (MBRs) and Executed Batch Records (EBRs) for clinical and commercial manufacturing.
• Develop and update engineering and qualification documentation for new and existing equipment and facilities.
• Create and maintain SOPs, work instructions, logbooks, and other GMP documentation.
• Ensure documents are formatted using approved templates and comply with internal document control procedures and regulatory expectations.
• Collaborate with subject matter experts (SMEs) to translate complex technical information into clear, concise, and user-friendly documents.

Batch Record Review

• Review executed batch records for accuracy, completeness, and compliance with cGMP and data integrity requirements.
• Identify, document, and help resolve discrepancies or errors in coordination with Manufacturing and Quality teams.
• Support timely batch record review and turnaround to meet product release timelines.

Compliance & Quality Support

• Ensure documentation complies with FDA 21 CFR Parts 210/211, ICH Q7, EU Annex 1, and internal quality standards.
• Support internal and external audits by providing controlled documentation and ensuring manufacturing record readiness.
• Participate in change control, CAPA, and deviation documentation activities as required.

Continuous Improvement

• Support implementation and use of electronic documentation systems (e.g., Dot Compliance) and participate in document migration initiatives.
• Identify opportunities to improve document clarity, efficiency, and traceability across manufacturing and quality operations.

Qualifications

Education

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Engineering, Technical Writing, or a related field preferred.
• Equivalent experience in a regulated pharmaceutical or biotechnology environment may be considered.

Experience

• 2–5 years of technical writing experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Hands-on experience with batch record preparation and review strongly preferred.
• Working knowledge of cGMP documentation standards and regulatory requirements (FDA, EMA, ICH, EU Annex 1).

Skills

• Excellent written and verbal communication skills with strong attention to detail.
• Proficiency in Microsoft Word, Excel, PowerPoint, and document control systems (e.g., Dot Compliance, MasterControl, Veeva).