Production Test Specialist

Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company's ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix' technology is designed to enable much earlier disease detection, better prognosis and precise 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, including oncology, neurology, cardiology, inflammation and infectious disease.

We are looking for an experienced and highly motivated Production Test Specialist to join our Technical Operations team. This position will be the primary bioburden testing specialist, and will broadly support lab operations across the technical operations team.

What You'll Do:

• Perform bioburden testing on samples from manufacturing, documenting and reporting results

• Work with quality assurance to develop AQL sampling plan for bioburden testing

• Develop and maintain standard operating procedures and work instructions for performing bioburden testing

• Perform maintenance and cleaning of equipment used for bioburden testing

• Perform/manage daily, weekly, monthly instrument maintenance and cleaning.

• Perform immunoassay testing on automated and semi-automated instrument platforms

• Perform peer review/approval of test data.

What We'll Expect From You:

• Bachelor's Degree in Chemistry/Biochemistry/Biology/related field; or Scientific Associate Degree with additional years of relevant experience.

• 1+ years of QC analytical experience working within the medical device or pharmaceuticals regulated product environment preferred.

• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry preferred.

• ELISA's and other plate-based methods for routine and non-routine use experience preferred.

• Exposure to creation of QC documents and quality events.

• Working knowledge of standard laboratory practices and safety

• Microbiology experience preferred but not required.

• Preferred to have hands-on experience and demonstrated organizational skills in a regulated analytical environment

• Demonstrated ability to work well within cross-functional teams as a team player

• Possess an ability to learn and master complicated concepts quickly and comfortably

• Ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude

• Strong attention to detail

• Strong computer and database skills

Working hour Requirements:

• Normal business hours with occasional demand of weekend work to support business needs.

Physical Demands:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, bend, kneel, hear, and talk.

• Close Vision

• Lift up to 25lbs

• Operate computer/office machines

• Ability to wear personal protection equipment

Travel Requirements:

• <5%

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: At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!

Quanterix is committed to a Diverse and Inclusive workplace. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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