Document Control Specialist II - Freenome

Why join Freenome?

Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. 

Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it's just the beginning. 

Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  

At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.

Become a Freenomer

Do you have what it takes to be a Freenomer? A "Freenomer" is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients' lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what's possible, one breakthrough at a time.

About this opportunity:

At Freenome, we are looking for a Document Control Specialist II to help expand our growing Quality team. In this role, you will support our quality and regulatory activities with various authorities, including the FDA, CLIA, and CAP, while ensuring compliance with quality systems like GMP, IVDR, and ISO. Working closely with cross-functional teams from Engineering, Regulatory Affairs, and Quality, you will play a key role in managing the document management system and learning management system. This position focuses on all aspects of Document Control and Training. 

We are looking for someone passionate about maintaining excellence in a fast-paced, high-performance environment, with the drive to contribute significantly to the growth of an organization dedicated to transforming cancer detection and treatment. You are passionate about, the ability to work in a fast-paced exciting environment with high expectations and performance accountability to guarantee a record of success while having a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer. 

The role reports to the Document Control Manager. 

What you'll do:

• Manage the processing, review, and approval of all revision-controlled documents
• Work within the electronic Quality Management System (eQMS) and Document control database
• Organize and plan the implementation of project-level document batches based on a solid foundation and understanding of key QMS components.
• Periodically review documents and records, for completeness and compliance with QSR 21 CFR § 820, ISO 13485 requirements, and Company procedures
• Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records
• Coordinate, manage, and lead programs related to quality improvement
• Ensure all documents for other QMS processes such as Approved Supplier List (ASL) and records, or external standards are current
• Support internal and external audits, supplier audits, and other RA/QA meetings, as needed
• Work with the QA Document Control Manager to manage document training when new documents are approved or existing documents are revised
• Support the administration of the eQMS, with accounts creation, training, troubleshooting, management, and system improvements as needed
  

Must haves:

• Experience: 5+ years of experience in Document Control within the medical device, biotech, life sciences, or similar industries
• Quality Systems Knowledge: Strong understanding of quality systems, including 21 CFR § 820, ISO 13485, and software development. Familiarity with ISO 15189 and GCLP is a plus
• Collaboration Skills: Proven ability to build collaborative working relationships; team-oriented yet able to work independently
• Adaptability: Ability to quickly adapt to changing priorities, manage workloads effectively, and deliver tangible results
• Communication: Excellent interpersonal and communication skills, both written and oral, to effectively interact with all levels of the organization
• Technical Proficiency: Highly proficient in using a variety of computer applications, with strong skills in Microsoft Word, Excel, and Google Workspace (gSuite) tools
  

Nice to haves:

• Knowledge of ComplianceQuest or similar platforms
• Knowledge of Jira Atlassian
  

Benefits and additional information:

The US target range of our base salary rate for new hires is $81,175 - $123,500. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

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