GMP Technical Writer/ Regulatory Documentation Specialist

Pay Scale :

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

Location : Norton, United States

Work Mode : Work From Office

What You’ll Do :

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).

What We’re Looking For :

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!

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