QMS Technical Writer and Document Control

QMS Technical Writer – Temporary QMS Technical Writer - Temporary is responsible for directly participating in a Quality Systems Integration Program, with primary responsibility being the creation of high-quality content. The Technical Writer will interact with individuals at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs, Supplier Quality, Supply Chain, Quality Control, Production, Process Development, Product Development, Software Development, R&D, Global Support in addition to building relationships with partners that manufacture products for the Wilsonville site. Key Responsibilities Participate in a Quality Systems Integration Program, primarily creating high-quality written content and supporting the Learning Management System. Conduct daily interactions with technical documentation, performing quantitated high-throughput tasks with attention to detail. Proofread, prepare, create, review, edit, and update Quality and Technical Documents including SOPs, Design Control Documentation (Design and Development Plan, Customer Requirements, Product Requirements, Design Outputs, Design Verification Protocol and Reports), Technical Reports, Manufacturing Processes, Product Release, Materials Management, Post Market Surveillance, Quality Incidents, Complaint Handling, AND CAPAs. Understand and be aware of the quality consequences which may occur from the improper performance of their specific job; know device defects that may arise in their area of responsibility, including product design, verification and validation, manufacturing and testing activities. Exhibit professional behavior with internal and external business associates, reflecting positively on the company and aligning with company policies. Learn complex concepts and communicate them in an engaging and clear manner understood by users. Manage and update revisions to technical literature. Maintain a comprehensive library of technical terminology and documentation. Oversee updates to the Training Matrix/Plans. Meet with managers to set up new or update current training plans. Build training curriculums. Oversee the Learning Management System. Provide new hire overview training. Carries out duties in compliance with established business policies. Adapt rapidly to a changing industry and adjust responsibilities, time, and objectives accordingly. Perform other duties and projects as assigned. Travel 10% of the time. Qualifications Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or equivalent combination of education and work-related experience. 3-5 years of technical writing experience in a GMP, Biotechnology, Pharmaceuticals or another regulated industry. Experience with Quality Assurance/Regulatory requirements in medical devices, IVD, EU IVDR/MDR, pharmaceuticals or biotechnology industry. Experience and knowledge of Next Generation Sequencing, Synthetic Biology Manufacturing, and Gene Manufacturing highly desirable. Experience with document management systems required. Experience with Learning Management Systems. Experience with MS Office Products required. Experience with Atlassian Confluence and JIRA preferred. Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required. Flexible, with ability to work effectively in a fast‑paced, dynamic environment with shifting and competing demands required. Equal Opportunity Employer Statement Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law. Compensation The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations. San Francisco Bay Area Pay Range: $28—$36 USD #J-18808-Ljbffr Merck & Co.