What are the responsibilities and job description for the Quality Specialist II position at 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 seeking a Quality Assurance Specialist II to help grow the Freenome Quality team. This position will support general QMS compliance activities such as batch record review, supplier management, nonconformances and CAPA. The ideal candidate will be engaged in supporting the development of the QMS and ensuring compliance based on US FDA Regulations 21 CFR § 820, ISO 13485:2016, in addition to CLIA, CAP, and NYSDOH guidelines.
The role reports to the Director, Quality Systems.This role will be an onsite role based in our Brisbane, California headquarters.
What you’ll do:
- Review batch records and Device History Records to ensure completeness and compliance, and disposition product accordingly
- Collaborate with QC and other functional areas to resolve errors and document nonconformities
- Author and revise SOPs
- Participate in regulatory inspections/audits and support inspection readiness activities
- Assist in performing internal audits and supplier audits
- Support the Nonconformance and CAPA systems including reviewing, processing, and approving records
- Assist in root cause investigations
- Work with QA management to develop KPIs and support the management review process
- Support QMS improvement and implementation activities
Must haves:
- BS/BA in a life science, engineering, or equivalent discipline; a combination of education and experience will be considered
- 3 years of QA experience in an FDA regulated industry, preferably Medical Device or IVD
- Ability to work effectively in a collaborative team environment
- Ability to adapt to changing priorities, manage multiple competing priorities with aggressive timelines within a fast-paced environment
- Attention to detail and commitment to Quality at every stage of the product life cycle
- Self-driven, ability to work under minimal supervision
- Excellent written and verbal communication
- Critical and analytical thinking, ability to assess risks and benefits, and develop effective solutions
Nice to haves:
- Quality Certifications (e.g., CQA, Six Sigma, ISO 13485 Lead Auditor, etc.)
- Experience using electronic Quality Management Systems
Benefits and additional information:
The US target range of our base salary 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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Salary : $81,175 - $123,500
