QMS Technical Writer and Document Control

Twist Bioscience Corporation • Wilsonville, OR

29d

About The Position

The QMS Technical Writer is responsible for directly participating in a Quality Systems Integration Program, with primary responsibility being the creating 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.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
• 3-5 years of experience of technical writing experience in a GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.
• Experience in Quality Assurance/Regulatory requirements in medical devices, IVD, EU IVDR/MDR, pharmaceuticals or biotechnology industry.
• Experience with document management systems required.
• Experience with Learning Management Systems.
• Experience with MS Office Products required.
• 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 is required.

Nice To Haves

• Experience and knowledge of Next Generation Sequencing, Synthetic Biology Manufacturing, and Gene Manufacturing highly desirable
• Experience with Atlassian Confluence and JIRA preferred.

Responsibilities

• Directly participate in a Quality Systems Integration Program, with the primary responsibility being the creation of high-quality written content and supporting Learning Management System.
• Daily interaction with technical documentation, with documentation tasks to be performed with quantitated high-throughput and attention to detail.
• Required to proofread, prepare, create, review, edit, and update Quality and Technical Documents including, but not limited to: 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, & CAPAs.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships.
• Learn complex concepts and communicate the information in a way that is engaging and understood by users.
• Manage and update revision to technical literature.
• Maintain a comprehensive library of technical terminology and documentation.
• Oversight for updating Training Matrix/Plans.
• Meet with Managers to set up new or update current Training Plans.
• Build Training Curriculums.
• Learning Management System oversight.
• Provide New Hire overview training.
• Carries out duties in compliance with established business policies.
• Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly.
• Perform other duties & projects as assigned.
• Ability to travel 10%.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 501-1,000 employees