Quality Control Analyst II

Company: Quanterix
Location: Billerica
Posted on: August 4, 2022

Job Description:

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. To continue our rapid growth, we are seeking a talented and highly motivated Quality Control Analyst II to join our growing organization. This position will be part of our Quality Control team, responsible for a variety of activities including immunoassay testing on automated and semi-automated platforms, advanced data analysis, and prioritization and coordination and new product launch readiness in accordance with current Good Manufacturing Practices (cGMP). What You'll Do: Perform QC testing of incoming raw materials, in-process samples, finished products per non-compendial methods for release Perform immunoassay testing on automated and semi-automated instrument platforms Accurately assess testing data to ensure product specifications are met and DHR is compiled in a compliant manner, according to current cGMP and site SOP's Monitor, analyze and trend inspection/testing results and quality data Perform peer review /approval of test data and write certificates of analysis Write, review and approve GMP documentation (SOPs, test methods, protocols, technical reports, specifications, etc) Author/manage planned and unplanned deviations, Investigations, Change Controls, CAPAs, and OOS investigations Actively support continuous process improvement to increase compliance and maintain a consistent state of laboratory controls What We'll Expect From You: Bachelor's Degree in Chemistry/Biochemistry/Biology or related field 3+ 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. Experience with the design, qualification and implementation of biological potency assays, ELISA's and other plate-based methods for routine and non-routine use Experience with manual and automated immunoassays testing, IVD immunoassay experience preferred Experience with the drafting of QC documents, drafting and execution of validation protocols, drafting and review of validation reports Working knowledge of standard laboratory practices and safety Candidates must have hands-on experience and demonstrated organizational skills in a regulated analytical/QC 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 Travel Requirements: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. 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. Our Culture: Quanterix is committed to a Diverse and Inclusive workplace. We have a Diversity Program with Executive Sponsorship. Our core values are Accountability, Teamwork, Trust, and Transparency OR ATT 2 . Meet some of our team HERE . 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. #LI-MM1

Keywords: Quanterix, Billerica , Quality Control Analyst II, Professions , Billerica, Massachusetts