Harbinger : Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Who we are

Harbinger Health, a Flagship-founded company, is pioneering early cancer detection. Harbinger aims to detect cancer, at the earliest stages, to save lives. Our platform leverages proprietary biological insights and artificial intelligence to enable high-resolution, molecular views on cancer from blood. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.

Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics (Nasdaq: FHTX), Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics (Nasdaq: SGTX).

Position Summary

Harbinger Health is looking for a motivated, highly responsible and broadly skilled Senior Quality Assurance Specialist to join our fast-growing team to support the launch of our early cancer detection platform. This role will be supporting the development and maintenance of the Quality Management System (QMS) and oversee validations, risk management and quality records review/approval including but not limited to the following:

 Key responsibilities

• Support the establishment and maintenance of the QMS in accordance with Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) and applicable state requirements.
• Provide quality oversight on validation activities for instrument/equipment, test method, automation and IT systems. Ensure that all validations are performed using a risk-based approach and necessary justifications are documented as required, sample sizes used in the validation are statistically sound, and the validations meet the applicable regulatory requirements.
• Oversee the risk management process. Ensure the risks associated with quality events, NCRs, CAPAs, complaints etc. are properly assessed and documented.
• Review/approve quality documents and records, including but not limited to quality events, nonconformance’s, CAPAs, CLIA laboratory test records, change controls, procedures, IT test cases, validation protocols and reports etc.
• Work closely with the Laboratory, Automation, Technical Development and Innovation teams to ensure the IT systems and applications meet the applicable regulatory and end users’ requirements.
• Drive process quality using statistical and engineering tools and methodologies in order to support design, development, validation, automation and routine operation of the CLIA Laboratory.
• Support the periodic review of the continuous improvement process. Work with cross functional teams to collect and evaluate the data and ensure key process indicators are monitored and evaluated properly for process performance and identify necessary improvement opportunities.  
• Monitor changes to applicable regulations and ensure policies and procedures reflect current regulatory requirements. Escalate/communicate quality/compliance issues to upper management promptly.
• Support the training program. Creates, develops, and delivers training courses; monitor training status, identifies trends, determine training effectiveness, and develops actions to remediate identified issues.
• Support external audits. Perform internal audits and supplier quality audits.
• Assist in quality event, nonconformance, CAPA, and complaints investigations as needed.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Previous quality engineering experience in regulated industry, i.e., CLIA laboratories, medical device, Biotech, or life science industries (5+ years with a bachelor’s degree, 3+ years with a master’s degree or 1+ year with a Ph. D degree) strongly preferred.
• Understanding of mechanical design and engineering requirements and constraints. Broad range of experience and techn