GMP Technical Writer/ Regulatory Documentation Specialist
π We’re Hiring: GMP Technical Writer! πAre you detail-oriented with a passion for clear and compliant documentation? Join our team and support manufacturing excellence by creating high-quality GMP documentation that meets global regulatory standards.π Location: Norton, United States
β° Work Mode: Work From Office
πΌ Role: GMP Technical Writer
Pay Scale:$75,362 — $114,386 (Dependent on Experience)What You’ll Do:
β Develop and Update Documentation: Write, edit, and maintain SOPs, batch records, work instructions, and other
technical documents to support manufacturing operations, equipment use, and quality control processes.
β Ensure Regulatory Compliance: Ensure all documentation complies with GMP, FDA, EMA, and other relevant
regulatory standards, as well as internal policies.
β Collaborate with Subject Matter Experts (SMEs): Work closely with manufacturing, quality assurance,
validation, safety, and engineering teams to gather technical information and ensure accuracy and clarity in
documentation.
β Streamline Processes: Translate complex technical processes into concise, user-friendly instructions to enhance
operational efficiency and reduce errors.
β Document Control: Manage document lifecycle, including version control, reviews, approvals, and archiving,
using electronic document management systems (EDMS).What We’re Looking For:
β Bachelor’s degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related
field.
β 2+ years of technical writing experience in a pharmaceutical, biotechnology, or regulated manufacturing
environment.
β Familiarity with GMP and regulatory requirements is highly preferred
β Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness
β Strong understanding of pharmaceutical manufacturing processes, equipment, and terminology.Ready to make an impact? π Apply now and let’s grow together!
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