Talent.com
QMS Technical Writer and Document Control
QMS Technical Writer and Document ControlTwist Bioscience • South San Francisco, CA, United States
QMS Technical Writer and Document Control

QMS Technical Writer and Document Control

Twist Bioscience • South San Francisco, CA, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

The QMS Technical Writer - Temporary 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.

Key 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%.
  • Qualifications

  • 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.
  • About Twist Bioscience

    Twist 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.

    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

    [job_alerts.create_a_job]

    Technical Writer • South San Francisco, CA, United States

    [internal_linking.similar_jobs]
    Technical Writer

    Technical Writer

    TradeJobsWorkForce • 94706 Albany, CA, US
    [job_card.full_time]
    Research, write, edit and proofread complex technical data.Create, maintain and update manuals, procedures, specifications and other documents. Create, maintain and update installation instructions,...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote M&A Associate - AI Trainer ($50-$60 / hour)

    Remote M&A Associate - AI Trainer ($50-$60 / hour)

    Data Annotation • Berkeley, California
    [filters.remote]
    [job_card.full_time] +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Technical Support Analyst III

    Technical Support Analyst III

    Public Health Institute • Berkeley, CA, United States
    [job_card.full_time] +1
    If you are a current and active PHI employee, do not use this site to apply for positions.Berkeley, CA;Work From Home - USA. The Public Health Institute (PHI) is an independent, nonprofit organizati...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Medical Writing

    Associate Director, Medical Writing

    Jazz Pharmaceuticals • Menlo Park, California, USA
    [job_card.full_time]
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Medical Writing Operations Specialist II

    Medical Writing Operations Specialist II

    Exelixis • Alameda, CA, United States
    [job_card.full_time]
    This role will perform quality review of regulatory documents to ensure content accuracy and consistency.Document scope includes but is not limited to clinical and nonclinical CTD Module 2 summarie...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Student Associate, Center for Health Sciences (Lab data collection)

    Student Associate, Center for Health Sciences (Lab data collection)

    SRI International • Menlo Park, CA, United States
    [job_card.part_time] +1
    Student Associate, Center for Health Sciences (Lab data collection).SRI's Center for Health Sciences is looking for a Student Associate to join our team! The student will help with data collection...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Contract Mandarin Document Review Attorney

    Contract Mandarin Document Review Attorney

    CONTACT GOVERNMENT SERVICES • San Francisco, CA, United States
    [job_card.full_time]
    Mandarin Document Reviewer Contact Review - Washington, DC Location : Remote Start Date : Negotiable EXPERIENCE & QUALIFICATIONS : Familiarity with document review workflows Examples : Privilege / ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Technical Writer for Utility Programs

    Technical Writer for Utility Programs

    VirtualVocations • Oakland, California, United States
    [job_card.full_time]
    A company is looking for a Technical Writer - Utility Programs.Key Responsibilities Develop, edit, and maintain procedures, work instructions, and administrative controls Support document contro...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Project Management Intern - Berkeley CA 2026

    Project Management Intern - Berkeley CA 2026

    Gilbane Building Company • Berkeley, CA, United States
    [job_card.full_time] +1
    Project Management Intern - Berkeley CA 2026.CAMPUS RECRUITS : Full-Time & Intern Opportunities - Internship Opportunities. Project Management Assistant - Temporary Internship - LOCAL CANDIDATES ONLY...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Bakery Order Writer (Buyer / Inventory Replenishment) - Full Time

    Bakery Order Writer (Buyer / Inventory Replenishment) - Full Time

    Whole Foods Market • Redwood City, CA, US
    [job_card.full_time]
    A career at Whole Foods Market is more than just the work you do- it's about your personal growth and creating meaningful change. Our purpose is to nourish people and the planet.That means improving...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Document Control Manager

    Document Control Manager

    AECOM • San Francisco, CA, United States
    [job_card.full_time]
    At AECOM, we're delivering a better world.Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Instructor Pool Writing and Literature UC Berkeley Extension

    Instructor Pool Writing and Literature UC Berkeley Extension

    InsideHigherEd • Berkeley, California, United States
    [job_card.part_time] +1
    Instructor Pool Writing and Literature UC Berkeley Extension.Instructor (Non-Senate, Non-Tenure Track).The compensation model varies depending upon the course delivery format.For a synchronous Li...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Technical Writer - E-Learning

    Technical Writer - E-Learning

    Skill • San Bruno, CA, United States
    [job_card.temporary]
    W2, Benefits and 401k matching.Note : This is a remote position.Candidates who reside in the areas below are given priority. Hoboken, NJ / San Bruno, CA / Bentonville, AR.Our retail client's Seller E...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Product Specialist, Medicare Programs

    Product Specialist, Medicare Programs

    San Francisco Health Plan • San Francisco, CA, United States
    [job_card.full_time]
    Director, Product and Growth, the Product Specialist Medicare Programs is responsible for tracking, analyzing, and monitoring compliance with Centers for Medicare and Medicaid Services (CMS) regula...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Technical Writer

    Technical Writer

    Mice Groups • San Mateo, California, United States
    [job_card.full_time]
    Technical Writer Location : Fremont, CA Onsite Flexible (Tuesday Mandatory Onsite) Contract : 1 Year assignment This position pays between $35. Pay for this contract position is based on market locati...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Compliance Analyst II

    Compliance Analyst II

    VOLEON • Berkeley, CA, United States
    [job_card.full_time]
    Voleon is a technology company that applies state-of-the-art AI and machine learning techniques to real-world problems in finance. For nearly two decades, we have led our industry and worked at the ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Principal, MLE - AI Governance

    Senior Principal, MLE - AI Governance

    Equinix, Inc. • Redwood City, CA, United States
    [job_card.full_time]
    Who are we? Equinix is the world's digital infrastructure company, shortening the path to connectivity to enable the innovations that enrich our work, life and planet. A place where bold ideas are ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate - PhD

    Associate - PhD

    Cornerstone Research • Menlo Park, CA, United States
    [job_card.full_time]
    US-CA-San Francisco and Silicon Valley | US-MA-Boston | BE-Brussels | US-IL-Chicago | UK-London | US-CA-Los Angeles | US-NY-New York | US-DC-Washington. Cornerstone Research provides economic and fi...[show_more]
    [last_updated.last_updated_30] • [promoted]