Senior Manufacturing Technical Procedure Writer

Advantage Technical
$55.00-$55.00
United States, Massachusetts, Norton
Apr 29, 2025
Job Title: Senior Technical Procedure Writer (GMP) Location: Norton Employment Type: Contract /Onsite] Job Summary 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. Key Responsibilities Develop and Update Documentation: Write, edit, and maintain SOPs, batch records, work instructions, and technical manuals that support operations, equipment use, and quality processes. Ensure Regulatory Compliance: Maintain strict alignment with GMP, FDA, EMA, ICH Q7, and internal quality policies in all documentation. Collaborate with SMEs: Work with Manufacturing, QA, Engineering, Validation, and Safety teams to gather technical details and translate them into clear, user-friendly documents. Streamline Processes: Break down complex or hazardous procedures into safe, logical, and readable formats to reduce operational risk and training errors. Manage Document Control: Use electronic document management systems (e.g., Veeva, MasterControl, Documentum) to handle version control, routing, approvals, and archival. Training Support: Help develop training materials and support onboarding by ensuring documentation is ready for implementation. Continuous Improvement: Review feedback from end-users to improve document usability, structure, and clarity. Audit Preparation: Ensure documentation is audit-ready, current, and aligned with inspection requirements. Ideal Candidate Profile Experience writing 10-15 documents/month, including high-risk or hazardous procedures requiring technical precision and clarity. Highly organized, meticulous, and capable of managing competing deadlines. Clear, concise communicator who can simplify technical jargon for a broad audience. Familiar with electronic documentation workflows, revision control, and best manufacturing practices. Qualifications Education: Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field. Experience: 5-7+ years of technical writing experience in a GMP-regulated manufacturing environment. Skills: Exceptional grammar, formatting, and document structuring skills. Deep understanding of pharmaceutical manufacturing, cleanroom operations, and documentation lifecycle. Proficiency in EDMS tools such as Veeva, MasterControl, Documentum, or Trackwise. Strong project management and prioritization capabilities. Working knowledge of 21 CFR Part 211, ICH Q7, and quality system regulations. Certifications (Preferred): Technical Writing (AMWA, STC), GMP compliance certifications. Work Environment Primarily office-based with occasional entry into cleanroom or manufacturing areas. Must be able to follow gowning and safety protocols as required by regulated environments. Key Competencies Strong attention to detail and commitment to accuracy Clear, precise, and reader-focused communication Excellent organizational and time management skills Collaborative mindset with a proactive and analytical approach to problem-solving Apply now to help drive quality, safety, and compliance through best-in-class documentation in pharmaceutical manufacturing. 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. About Advantage Technical With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com. Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment. All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.