Tap Growth AI
GMP Technical Writer/ Regulatory Documentation Specialist
Tap Growth AI, Norton, Massachusetts, us, 02766
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!
#J-18808-Ljbffr
$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!
#J-18808-Ljbffr