QMS Technical Writer and Document Control at Twist Bioscience

Portland, Oregon, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, Medical DevicesIndustries

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 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 is required
Ability to travel 10%

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
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
Understand and be aware of the quality consequences which may occur from the improper performance of their specific job; have awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Exhibit 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
Carry 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

Skills

Key technologies and capabilities for this role

Technical WritingDocument ControlSOPsDesign ControlProofreadingEditingQuality Management SystemsCAPARegulatory DocumentationLearning Management System

Questions & Answers

Common questions about this position

What qualifications are required for the QMS Technical Writer role?

A Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field is required, along with 3-5 years of technical writing experience.

Is travel required for this position?

Yes, the role requires the ability to travel 10%.

What are the main responsibilities of the Technical Writer?

The role involves creating high-quality written content, proofreading, editing, and updating Quality and Technical Documents like SOPs and Design Control Documentation, interacting with multiple departments, and overseeing the Learning Management System and training plans.

What is the salary range for this position?

This information is not specified in the job description.

What experience makes a strong candidate for this role?

Candidates with 3-5 years of technical writing experience in a scientific or regulated industry, a relevant Bachelor's degree, and the ability to handle complex technical documentation and interact across departments will stand out.

Twist Bioscience

Produces synthetic DNA for biotechnology applications

About Twist Bioscience

Twist Bioscience specializes in creating synthetic DNA for applications in biotechnology, pharmaceuticals, and research. Their proprietary platform allows for the quick and accurate production of DNA sequences, providing clients with products like genes, oligo pools, and variant libraries. The company stands out by offering high-quality DNA at competitive prices, making them a valuable partner for academic institutions and pharmaceutical companies. Twist Bioscience aims to support advancements in personalized medicine and biotechnology through their innovative DNA synthesis solutions.

South San Francisco, CaliforniaHeadquarters

2013Year Founded

$236.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Disability Insurance

Life Insurance

401(k) Retirement Plan

Risks

Increased competition from Ginkgo Bioworks may impact Twist's market share.

Dependency on AI technologies could pose integration and operational challenges.

New CIO appointment may lead to transitional challenges in IT strategy and operations.

Differentiation

Twist Bioscience uses a unique silicon-based DNA synthesis platform for precision and scale.

They offer high-quality DNA sequences at competitive prices, attracting diverse clients.

Their proprietary platform provides instant feedback on DNA sequence synthesis feasibility.

Upsides

Growing demand for synthetic DNA in personalized medicine boosts Twist's market potential.

Collaboration with Absci leverages AI to accelerate antibody discovery and drug development.

Synthetic biology market projected to grow at 28.8% CAGR, benefiting Twist's growth.

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