Quality Control Analyst II
Company: Quanterix
Location: Billerica
Posted on: August 4, 2022
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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
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