Technical Writer

Scientific Recruiter | 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. 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). Seniority Level Associate Employment Type Full-time Job Function Accounting/Auditing and Writing/Editing Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing #J-18808-Ljbffr ClinLab Solutions Group