QMS Technical Writer and Document Control jobs in United States
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Twist Bioscience · 1 day ago

QMS Technical Writer and Document Control

Twist Bioscience is a company specializing in DNA synthesis to support advancements in various fields. The QMS Technical Writer is responsible for creating high-quality documentation and participating in the Quality Systems Integration Program, ensuring compliance with quality standards.

B2BBiotechnologyChemicalHealth CareLife Science
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H1B Sponsor Likelynote

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%

Qualification

Quality Assurance experienceDocument management systemsTechnical writingLearning Management SystemsMS Office ProductsNext Generation SequencingSynthetic Biology ManufacturingGene ManufacturingCommunication skillsAdaptability

Required

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

Preferred

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

Benefits

Bonus
Equity
Generous benefits package

Company

Twist Bioscience

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Twist Bioscience is a biotechnology company that offers synthetic DNA solutions, gene synthesis, and variant libraries.

H1B Sponsorship

Twist Bioscience has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (14)
2023 (22)
2022 (19)
2021 (4)
2020 (6)

Funding

Current Stage
Public Company
Total Funding
$553.11M
Key Investors
Capital World InvestorsBiomatics Capital PartnersIllumina
2022-02-09Post Ipo Equity· $250M
2020-01-27Post Ipo Equity· $50M
2018-10-30IPO

Leadership Team

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Emily Leproust
CEO
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Siyuan Chen
Chief Technology Officer
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Company data provided by crunchbase