Quality Specialist II

South San Francisco, CA
Dec 01, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Quality Specialist II

About the Role

As a Quality Specialist, you will be responsible for reviewing  development protocols and reports, supporting data analysis of performance, data integrity checks, building DHF index, review of documentation, support of development, and supporting incoming quality as needed. The Quality Specialist role plays an integral role in supporting compliance activities with FDA, ISO, clinical laboratory and other IVD regulations. This individual also supports the company’s quality system activities and continuous improvement to ensure compliance with the FDA 21 CFR § 820 and ISO 13485 and 15189 as well as CLIA, CAP, and applicable federal and state requirements. 

How you’ll contribute:

  • Review records and documents for all the development components for completeness, integrity and compliance with QSR and ISO requirements (necessary for validation, verification, compliance efforts)
  • Support risk management activities
  • Support data analysis of performance, data integrity, building DHFs, audit support, review of documentation, support of development 
  • Review reports for compliance with protocols, SOP’s and regulations
  • Participate in external and internal inspections/audits, assist in preparing, conducting the audits and following up on the audit findings.Assist in maintaining a constant state of inspection readiness
  • Support QMS gap assessment and help develop the QMS system by working directly with the Quality System Manager
  • Review development protocols and reports, support data analysis of performance, and data integrity activities.
  • Support Facility Validation activities with respect to qualifying and validating systems and processes.
  • Support Equipment and system validation activities by collaborating with fellow quality and service engineering team members as needed
  • Performs other related duties as assigned by manager
  • Represent Quality at cross functional meetings
  • Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.

What you’ll bring: 

  • Bachelor’s degree in engineering, biology or a related scientific discipline
  • Working knowledge of medical device (required) / in vitro diagnostic (IVD) (preferred)regulations (e.g., FDA 21 CFR § 820, ISO 13485, IVDR, ISO 15189, CAP/CLIA and other applicable quality and regulatory standards)
  • Demonstrated project management skills
  • 3-5 years of experience in medical device/biotechnology industry, with prior experience in an FDA regulated Medical device environment, in vitro diagnostics or a CAP/CLIA laboratory prefered
  • A commitment to quality and a high level of self-motivation
  • Problem solving capability, ability to drive implementation of root cause identification and corrective actions.
  • Excellent verbal and written communications skills
  • Strong interpersonal skills and an ability to work as an effective member of a cross-functional team
  • Excellent organizational skills and high attention to detail
  • Proficiency in data compilation, analysis, presentation, and document writing skills.
  • Working knowledge of cloud-based applications (Gsuite- Docs, Sheets and Slides) as well as common Microsoft applications
  • Strong time management skills and the ability to multi-task in a fast-paced environment.
  • Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.

About Freenome

Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer.

We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw.  By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science. 

Our recent $270 Million Series C brings our financing to over $500 million from investors, including;  Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences. 

Our Science

Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure. 

By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome’s datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.  

Our Culture

Freenomers are technical, creative, visionary, grounded, empathetic, and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve.  We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives.  We believe in empowering and supporting each other in a collaborative and dynamic environment. 

What does a successful person look like at Freenome?

Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.