At GenapSys we are working to power the world of healthcare and diagnostics with advanced DNA sequencing technology. Our sequencing instrument platform leverages a proprietary electrical microfluidic sequencing chip with a scalable number of detectors, enabling a wide range of applications including targeted sequencing in oncology, pharmacogenomics and genome-wide sequencing in microbiology and others. We believe in a world where every researcher has a compact, scalable, and affordable sequencer in their own lab, empowering the democratization of genetic sequencing. Our novel sequencing method is revolutionizing genomics discovery, biomedical research, healthcare, diagnostics, agriculture, and a variety of other fields.
About the Role:
The Technical writer position is responsible for documentation of processes and specifications utilized in the Operations department. They will work closely with Manufacturing, Quality Control/Assurance, Research & Development, Engineering and Logistics teams to translate processes into approved internal documents. They will author and revise documents and identify areas of improvement.
- Understand processes from both the perspective of the user and the quality system.
- Translate the needs of the user into functional process documents while maintaining compliance with regulatory and quality requirements.
- Translate and iterate on documents from manufacturing, quality control/assurance, R&D, engineering and logistics departments to an IVD (in-vitro diagnostic)/cGMP environment.
- Writes, edits, and reviews cGMP manufacturing documents, validation protocols, SOPs, and engineering related material.
- Project management of documentation revisions.
- Engineering Change Orders
- Author and revise documentation.
- Assist in documentation hierarchical organization.
- Work across departments to ensure needs are met and that input is incorporated in documentation.
- Maintain global tracking of documents within the technical writing team.
- Assess new requests for level of effort and time/resource allocation.
- Point of contact cross-functionally for status of documentation projects.
- 2+ years in a Life Sciences, Biotechnology industry setting
- 1+ year of technical or scientific writing experience
- 2+ years of laboratory experience (preferred)
- Experience managing multiple projects, resources, and/or teams
- Experience in cGMP and ISO9001 environments
- Must have demonstrated expertise in authoring SOPs or similar process directed documentation
- Microsoft Word and Adobe Acrobat
- Flowcharting software (preferred)
- Adaptable to fast-paced, dynamic work environments and shifting demands.
- Highly collaborative, team-oriented, and an effective communicator.
- Organized and detail oriented. Ability to handle multiple projects.
- Passion for making a difference in the world.
- Able to work effectively in a matrix organization.
What we offer (US based-employees):
- Competitive compensation and generous stock options.
- Comprehensive, industry-leading medical, dental and vision benefits for employees and dependents.
- Pre-tax savings plans for health care, child care, elder care, public transportation and parking expenses.
- 401(k) retirement plan with matching employer contribution.
- Free daily catered gourmet lunches and snacks.
- For those emergency moments – long and short-term disability, life insurance (2x salary) and an employee assistance program.
- Work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, the opportunity to work on problems that matter in a highly collaborative environment.
- Flexible working environment
GenapSys does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website or to any GenapSys employee. GenapSys will not pay fees to any third party agency or firm and will not be responsible for any agency fees absent a formal agreement.
A diverse and inclusive workplace where we learn from each other is an integral part of GenapSys’ culture. We actively welcome people of different backgrounds, experiences, abilities and perspectives. We are an equal opportunity employer and a great place to work. Join us and help us achieve our mission!