<p>Job Title: Senior Technical Procedure Writer (GMP)</p> <p>Location: Norton</p> <p>Employment Type: Contract /Onsite]</p> <p>Job Summary</p> <p>The Manufacturing Technical Procedure Writer is responsible for creating, revising, and maintaining clear, accurate, and compliant standard operating procedures (SOPs), batch records, and other technical documentation that support pharmaceutical manufacturing operations. This role ensures that all documentation adheres to Good Manufacturing Practices (GMP), regulatory requirements (e.g., FDA, EMA), and internal quality standards. The ideal candidate is detail-oriented, has strong technical writing skills, and a deep understanding of pharmaceutical manufacturing processes.</p> <p>Key Responsibilities</p> <ul> <li> <p>Develop and Update Documentation: Write, edit, and maintain SOPs, batch records, work instructions, and technical manuals that support operations, equipment use, and quality processes.</p> </li><li> <p>Ensure Regulatory Compliance: Maintain strict alignment with GMP, FDA, EMA, ICH Q7, and internal quality policies in all documentation.</p> </li><li> <p>Collaborate with SMEs: Work with Manufacturing, QA, Engineering, Validation, and Safety teams to gather technical details and translate them into clear, user-friendly documents.</p> </li><li> <p>Streamline Processes: Break down complex or hazardous procedures into safe, logical, and readable formats to reduce operational risk and training errors.</p> </li><li> <p>Manage Document Control: Use electronic document management systems (e.g., Veeva, MasterControl, Documentum) to handle version control, routing, approvals, and archival.</p> </li><li> <p>Training Support: Help develop training materials and support onboarding by ensuring documentation is ready for implementation.</p> </li><li> <p>Continuous Improvement: Review feedback from end-users to improve document usability, structure, and clarity.</p> </li><li> <p>Audit Preparation: Ensure documentation is audit-ready, current, and aligned with inspection requirements.</p> </li></ul> <p>Ideal Candidate Profile</p> <ul> <li> <p>Experience writing 10-15 documents/month, including high-risk or hazardous procedures requiring technical precision and clarity.</p> </li><li> <p>Highly organized, meticulous, and capable of managing competing deadlines.</p> </li><li> <p>Clear, concise communicator who can simplify technical jargon for a broad audience.</p> </li><li> <p>Familiar with electronic documentation workflows, revision control, and best manufacturing practices.</p> </li></ul> <p>Qualifications</p> <ul> <li> <p>Education: Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field.</p> </li><li> <p>Experience:</p> </li><li> <p>5-7+ years of technical writing experience in a GMP-regulated manufacturing environment.</p> </li><li> <p>Skills:</p> </li><li> <p>Exceptional grammar, formatting, and document structuring skills.</p> </li><li> <p>Deep understanding of pharmaceutical manufacturing, cleanroom operations, and documentation lifecycle.</p> </li><li> <p>Proficiency in EDMS tools such as Veeva, MasterControl, Documentum, or Trackwise.</p> </li><li> <p>Strong project management and prioritization capabilities.</p> </li><li> <p>Working knowledge of 21 CFR Part 211, ICH Q7, and quality system regulations.</p> </li><li> <p>Certifications (Preferred): Technical Writing (AMWA, STC), GMP compliance certifications.</p> </li></ul> <p>Work Environment</p> <ul> <li> <p>Primarily office-based with occasional entry into cleanroom or manufacturing areas.</p> </li><li> <p>Must be able to follow gowning and safety protocols as required by regulated environments.</p> </li></ul> <p>Key Competencies</p> <ul> <li> <p>Strong attention to detail and commitment to accuracy</p> </li><li> <p>Clear, precise, and reader-focused communication</p> </li><li> <p>Excellent organizational and time management skills</p> </li><li> <p>Collaborative mindset with a proactive and analytical approach to problem-solving</p> </li></ul> <p>Apply now to help drive quality, safety, and compliance through best-in-class documentation in pharmaceutical manufacturing.</p> <p>After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.</p>