Quality Control Analyst II

TalentBoost (Quanterix) - Billerica, MA

To continue our growth, we are hiring a Quality Control Analyst II located in Billerica, MA. 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
  • Author and/or revise GMP documents such as SOPs, test methods, work instructions etc
  • Author/manage planned and unplanned deviations, Investigations, Change Controls, CAPAs, and OOS investigations
  • Perform/manage daily, weekly, monthly instrument maintenance and cleaning
  • Schedule and organize calibrations, preventive maintenance of laboratory equipment / instruments in timely manner
  • Actively support continuous process improvement to increase compliance and maintain a consistent state of laboratory controls
  • Provide mentoring and training to junior analysts on laboratory tests, skills, and lab processes
  • Other duties as assigned

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 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
  • Working knowledge of standard laboratory practices and safety
  • Candidate 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

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: Tuesday, May 30, 2023

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