About Our Company
Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.
The Opportunity
Universal DX is seeking a Document Specialist with strong expertise in Laboratory Operations and IVD Manufacturing documentation to join our growing Lab and Manufacturing Ops team. In this role, you will operate in close partnership with Quality Document Control and Design Quality to ensure accurate, audit-ready, and traceable documentation throughout the product development and manufacturing lifecycle. You will play a key role in supporting the creation, organization, maintenance, and lifecycle management of documentation and associated controlled documents generated by the Laboratory and Manufacturing teams as part of the Design Controlled IVD Product Development Programs. Your contribution will directly support the execution of our strategy and enable the company’s growth and expansion in the Life Sciences sector, particularly across the USA and the EU.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.
How You’ll Contribute
This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.
We are looking for passionate changemakers to be a part of our journey in this expansive time for us.
Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.
The Opportunity
Universal DX is seeking a Document Specialist with strong expertise in Laboratory Operations and IVD Manufacturing documentation to join our growing Lab and Manufacturing Ops team. In this role, you will operate in close partnership with Quality Document Control and Design Quality to ensure accurate, audit-ready, and traceable documentation throughout the product development and manufacturing lifecycle. You will play a key role in supporting the creation, organization, maintenance, and lifecycle management of documentation and associated controlled documents generated by the Laboratory and Manufacturing teams as part of the Design Controlled IVD Product Development Programs. Your contribution will directly support the execution of our strategy and enable the company’s growth and expansion in the Life Sciences sector, particularly across the USA and the EU.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.
How You’ll Contribute
- Support the Laboratory and Manufacturing Ops teams on the creation, internal functional review, organization, maintenance, and lifecycle management of controlled documentation (DHF) and associated documents, including SOPs, work instructions, forms, batch records, protocols, reports, and technical documentation.
- Partner with Quality to ensure documentation compliance with applicable regulatory requirements, internal quality management system (QMS) standards, and document control procedures.
- Ensure documents meet internal formatting, version control, and metadata standards.
- Support the coordination of document reviews and approvals in coordination with PMO and Quality teams.
- Conduct gap assessments in partnership with Quality to identify compliance risks, improvement opportunities, and alignment with internal and external quality and regulatory requirements.
- Serve as a central point of contact for controlled documentation within the Lab Ops and Manufacturing Ops teams.
- Master’s degree in Quality Management Systems.
- Bachelor’s degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or related discipline (or equivalent experience).
- 3-5+ years of document control or quality documentation experience in a regulated environment (IVD, medical device, biotech, or pharmaceutical preferred).
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, CLIA lab documentation, and other applicable regulations within FDA 21 CFR related to manufacturing and design control principles.
- Experience supporting Design History Files (DHF), technical files (e.g. DMR) and general operating procedures generated by Laboratory and Manufacturing Operations teams.
- Familiarity with risk management documentation (e.g., ISO 14971) is a plus.
- Audit support experience (internal, FDA, ISO, or notified body) is a plus.
- Strong attention to detail and document organization skills.
- Good communication skills in English, both spoken and written.
- Constancy, effort, patience and perseverance.
- Be consistent, committed, competent, responsible and organized.
- 22 days of PTO with the possibility to carry over 10 days to the following year.
- Company Holidays, plus your Birthday off!
- Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
- Flexible work schedule
- And more to come!
This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.
We are looking for passionate changemakers to be a part of our journey in this expansive time for us.