Quality Assurance Specialist II

TalentBoost (Quanterix) - Billerica, MA

Quanterix is a company on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping researchers advance the science of precision health. Simoa® is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. We are hiring a Quality Assurance Specialist II located in Billerica, MA.

Quanterix Accelerator Laboratory Services provides contract research and clinical testing supporting cutting edge research in cancer and neurology. Quanterix is seeking a talented and highly motivated Quality Assurance Specialist II to join our growing Accelerator Laboratory Services Quality group. The Quality Assurance Specialist will be responsible for supporting the assessment of the laboratory’s compliance with CLIA, ISO15189, and GCLP by participating in quality compliance activities and initiatives.

What You’ll Do:

  • Support company compliance with national, state, and international Quality System regulations consistent with the strategic priorities of the business by evaluating current procedures and practices versus these regulations and making improvements where necessary
  • Support Internal Audit Program by performing Internal Sample Tracer audits and other audits as needed
  • Ensure Accelerator Laboratory Service’s compliance with CLIA regulations, ISO15189 standards, and GCLP guidelines through the assessment of established Quality Systems
  • Participate in multi-functional teams on a wide variety of quality activities to continuously improve the quality systems used throughout the company
  • Support efforts to continuously improve existing Quality Management System (QMS), including extending to higher level standards such as ISO 15189 and NYS clinical laboratory regulations
  • Support audits performed by customers and regulatory agencies
  • Support regular KPI reporting related to overall health of various equipment, programs and QMS, at direction of Director of Quality Assurance
  • Provide QA support of investigations, including non-conformance, SCARs, CAPA, root cause analysis, complaints, out-of-specification, and environmental excursions
  • Represent the Quality Assurance Group on project teams and perform associated QA activities including but not limited to process compliance, review and approval of associated documentation, facilitate the development of appropriate quality metrics, etc.
  • Perform quality review of validation protocols and reports

What We’ll Expect From You:

  • Bachelor’s degree in the life sciences, master’s degree preferred
  • 3-5 years of experience in the in a Quality role supporting CLIA, ISO15189, or GCLP
  • Experience being the Quality Assurance project team representative on projects with tight timelines
  • Good understanding of CLIA, ISO15189, and or GCLP
  • Demonstrated experience writing, reviewing and approving quality policies and standard operating procedures
  • Ability to participate in groups resolving active quality issues or process improvement activities
  • Ability to handle multiple priorities and meet established deadlines
  • Exceptional interpersonal and written/verbal communication skills
  • Excellent analytical skills and a keen attention to detail
  • Strong root cause analysis skills
  • Keen attention to detail
  • Experience with testing laboratory operations
  • Internal Auditor certificate desired

Why You’ll Like Working For Us:

Our Technology: Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

Our Commitment To Employees: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free bagels every Monday morning, and free snacks and drinks every day! Quanterix hosts Virtual Bingo nights with all employees when we can see families, pets, and win amazing prizes. Unwind on Tuesdays and Thursdays with a virtual yoga session. In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Maternity & Paternity leave, Family Medical Leave, Fertility Assistance, Dependent Care, Military Leave and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance.

TalentBoost is now Ignyte AI.

This job has been posted by Ignyte AI on behalf of Quanterix. Ignyte AI is committed to the fundamental principle of equal opportunity and equal treatment for every prospective and current employee. It is the policy of Ignyte AI not to discriminate based on race, color, national or ethnic origin, ancestry, age, religion, creed, disability, sex and gender, sexual orientation, gender identity and/or expression, military or veteran status, or any other characteristic protected under applicable federal, state or local law.

Posted On: Monday, May 22, 2023

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