Quality Control Specialist
Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.
As a Quality Control Specialist you will join our Operations team and be part of a highly collaborative team to make an immediate impact on early cancer detection. The primary focus of the position is to perform QC testing needs for Freenome's multiomics IVD product. These testing can include NGS-based methods and Immunoassay-based methods. Secondary to the role is around documentation; the work requires keeping meticulous and organized records, excellent attention to detail, the ability to prioritize and be flexible with multiple tasks and schedules. This position will report to the QC manager.
- Perform release and stability testing of non-clinical, consumables, and reagent materials according to procedures
- Author, review and maintain documentation, such as Standard Operating Procedures, Work Instructions, QC Records/Forms, Non-conformances and other necessary documentation for regulatory compliance.
- Record, analyze and trend data using good documentation practices.
- Monitor QC data.
- Investigate material quality issues.
- Prepare material quality reports by collecting, analyzing and summarizing information and trend.
- Participate in validation of analytical methods to cGMP and GLP standards.
- Build and maintain strong knowledge of fundamentals and regulatory requirements applicable to laboratory operations and quality control.
Your background, perspective and experience:
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Bioengineering or similar field.
- Minimum of 2+ years of industry experience in Operations/Quality Control.
- Knowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISO.
- Strong hands on experience with laboratory automation such as Hamilton, Tecan, Biotek, Bravos, etc.
- Strong hands on experience with a variety of analytical methods will be considered, including NGS sequencing, Immunoassays, spectroscopy, PCR, CE, GC, LC, light scattering, etc.
- Knowledge of/experience with softwares such as LIMS, Netsuite, Softmax Pro, Bartender, etc.
- Technical writing experience, including Standard Operating Procedures, Work Instructions, QC Records/Forms, Non-conformances and laboratory investigations.
- Exceptional attention to detail and commitment to producing high-quality data.
- Willingness to learn and follow regulatory guidelines while working in a fast paced environment.
- Strong communication and organizational skills.
- Strong interpersonal skills and desire to work within a highly collaborative team; adept at building cross-functional relationships with individuals from diverse backgrounds.
As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy. If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster. If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.
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.
We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures.
A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
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.
Benefits include but are not limited to:
- Competitive compensation
- Pre-IPO equity
- Flexible PTO (exempt) and generous PTO (non-exempt)
- Comprehensive health coverage, including medical, dental, and vision
- Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
- 401(k) plan
- $250.00 new hire stipend to enhance your home office experience
- Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts
Applicants have rights under Federal Employment Laws.
Notice to agencies:
Our in-house Talent Acquisition Team manages all employment opportunities at Freenome. Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee.
We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.
Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.