To continue our growth, we are hiring a Quality Control Analyst I 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 cGMP.

To continue our rapid growth, we are seeking a talented and highly motivated QC Analyst 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 cGMP.

Key Responsibilities:

• Perform QC testing of incoming consumables and raw materials per compendial and non-compendial methods for GMP use in manufacturing
• 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
• Participate in authoring/editing new or approved GMP documentation such as SOPs, test methods, work instructions etc.
• Create Quality documents and participate in investigation process.
• Perform/manage daily, weekly, monthly instrument maintenance and cleaning.
• Actively support continuous process improvement to increase compliance and maintain a consistent state of laboratory controls

Skill and Knowledge Requirements:

• Preferred to 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

Minimum Experience and Education:

• Bachelor’s Degree in Chemistry/Biochemistry/Biology or related field preferred
• 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

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

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