What are the responsibilities and job description for the Technical Writer position at ClinLab Solutions Group?
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).