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.
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We are looking for an experienced and highly motivated Senior Quality Control Incoming Technician in Billerica, MA to join our Quality Control team. This individual will be responsible for a variety of activities including raw material inspection and testing in accordance with current Good Manufacturing Practices (cGMPs).
What You'll Do:
- Oversee QC technicians to ensure timely release of raw materials
- Oversee the scheduling of raw material testing, and release in a manner such that supports the manufacturing schedule
- Lead end of year cycle count activity
- Responsible for maintaining the integrity of work areas including maintenance and calibration of measuring and monitoring devices, general work center safety and cleanliness in compliance with established Quality standards
- Create, analyze, verify, and approve result reports and material release records
- Revise/review specifications, SOPs, and other documents regarding raw material testing
- Identify and implement improvements in documentation and other process improvements, lead investigations and resolutions of raw mater and vendor related issues and general continuous improvement activities
- Lead Out of Specification and NCMR investigations related to raw material performance and procedural or analytical deviations or errors in the laboratory and ensure corrective actions and or SCARS are developed and implemented
- Lead and facilitate initial and periodic training of QC Technicians to ensure standard adherence to laboratory practices, techniques, and adherence to cGxP and other applicable regulations and standards
- Coordinate/Conduct inspection of out-going materials
- Interact with auditors/clients during visits and tours
What We'll Expect From You:
- Bachelor's degree in biology, Chemistry or Life Sciences preferred
- 5+ years in raw materials testing, inspection and release or similar experience
- Knowledge of GxP regulations in a cGxP environment
- Knowledge of raw materials sampling techniques and of sampling plans
- Direct supervisory experience strongly preferred
- Strong organizational skills to be able to manage multiple tasks simultaneously, and the ability to appropriately prioritize tasks
- Strong attention to detail to produce accurate, precise, and reproducible data
- Strong verbal and written communication skills
- Ability to work well within cross-functional teams as a team player
- Skilled at analyzing data, summarizing results, and generating performance metrics to drive corrective actions
- Possess an ability to learn and master complicated concepts quickly and comfortably
- Strong work ethic with ability to meet rapidly evolving and dynamic business priorities
- Possess the ability to proactively adapt to rapid changes in business priorities and foster teamwork among employees to maintain high quality standards
- Ability to drive functional, technical, and operational excellence
- Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness
- Ability to manage timelines and coordinate work schedules of employees
- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, bend, kneel, hear, and talk
- Lift up to 25lbs
- Operate computer/office machines
- Ability to wear personal protection equipment
- < 5% travel
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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