Twist Bioscience
QMS Technical Writer and Document Control (Temporary)
Twist Bioscience, San Francisco, California, United States, 94199
QMS Technical Writer-Temporary Role
The Contract 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, Legal and Finance in addition to building relationships with partners that develop and manufacture products for Twist globally.
What You’ll Be Doing
Directly participate in a Quality Systems Integration Program, with the primary responsibility being the creator of high-quality written content.
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.
Learn complex concepts and communicate the information in a way that is engaging and understood by users.
Convert, modify, and update documents from previous Document Control System to Word/gDoc templates.
Maintain a comprehensive library of technical terminology and documentation.
Assist with Document Control Administrative tasks such as processing document change request, routing releasing documents.
Provide feedback and coach new users to the Document Control process.
Carries out duties in compliance with established business policies.
Provide technical support for Twist’s Electronic Quality Management Systems (EQMS) (e.g., Master Control, etc.) development and implementation.
Perform day to day administration activities on EQMS as per approved procedures.
Work closely and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need.
Provide support for EQMS Help Desk tickets.
Perform other duties & projects as assigned.
Ability to travel 5%.
Follow regulatory and ISO 13485 requirements.
What You’ll Bring to the Team
Bachelor’s degree in Business, Pharma, Tech, Biomedical or equivalent combination of education and work-related experience.
Minimally 3 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 and knowledge of Next Generation Sequencing, Synthetic Biology Manufacturing, and Gene Manufacturing highly desirable.
Experience with Google Suite and/or MS Office Products required.
Experience with Master Control, Atlassian Confluence and/or 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 is required.
About Twist BioscienceTwist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
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.
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The Contract 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, Legal and Finance in addition to building relationships with partners that develop and manufacture products for Twist globally.
What You’ll Be Doing
Directly participate in a Quality Systems Integration Program, with the primary responsibility being the creator of high-quality written content.
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.
Learn complex concepts and communicate the information in a way that is engaging and understood by users.
Convert, modify, and update documents from previous Document Control System to Word/gDoc templates.
Maintain a comprehensive library of technical terminology and documentation.
Assist with Document Control Administrative tasks such as processing document change request, routing releasing documents.
Provide feedback and coach new users to the Document Control process.
Carries out duties in compliance with established business policies.
Provide technical support for Twist’s Electronic Quality Management Systems (EQMS) (e.g., Master Control, etc.) development and implementation.
Perform day to day administration activities on EQMS as per approved procedures.
Work closely and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need.
Provide support for EQMS Help Desk tickets.
Perform other duties & projects as assigned.
Ability to travel 5%.
Follow regulatory and ISO 13485 requirements.
What You’ll Bring to the Team
Bachelor’s degree in Business, Pharma, Tech, Biomedical or equivalent combination of education and work-related experience.
Minimally 3 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 and knowledge of Next Generation Sequencing, Synthetic Biology Manufacturing, and Gene Manufacturing highly desirable.
Experience with Google Suite and/or MS Office Products required.
Experience with Master Control, Atlassian Confluence and/or 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 is required.
About Twist BioscienceTwist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
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.
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