GMP Technical Writer​/Regulatory Documentation Specialist

Pay Scale: $75,362 — $114,386 (Dependent on Experience)

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Location:

Norton, United States
⏰ Work Mode:
Work From Office

• 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.
• Ensure Regulatory Compliance:
  Ensure all documentation complies with GMP, FDA, EMA, and other relevant regulatory standards, as well as internal policies.
• 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.
• Streamline Processes:
  Translate complex technical processes into concise, user-friendly instructions to enhance operational efficiency and reduce errors.
• Document Control:
  Manage document lifecycle, including version control, reviews, approvals, and archiving, using electronic document management systems (EDMS).

• Bachelor’s degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field.
• 2+ years of technical writing experience in a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Familiarity with GMP and regulatory requirements is highly preferred.
• Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness.
• Strong understanding of pharmaceutical manufacturing processes, equipment, and terminology.

Ready to make an impact? 🚀 Apply now and let’s grow together!