To continue our rapid growth, we are seeking a talented and highly motivated Quality Control Supervisor located in Billerica, MA, to join our growing strategic corporate collaboration group. This position is responsible for organizing and ensuring the successful release and performance testing of all incoming raw materials which will be used in Assay manufacturing and in the inspection of finished goods. The ideal candidate will be an innovative leader with a depth of experience in raw material control, specification management, testing, coordinating and documenting controlled studies.

Key Responsibilities:

• Oversee team of QC technicians and analysts through effective planning, mentoring, directing and coordination of development activity.
• Oversee the scheduling of in-process and finished goods release testing in a manner such that supports the manufacturing schedule
• 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
• Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP, GLP and ISO 9001 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, leaf investigations and resolutions of raw mater and vendor related issues and general continuous improvement activities
• Lead Out-of-Specification (OOS) and NCMR investigations related to laboratory testing and procedural or analytical deviations or errors and ensure corrective actions are developed and implemented
• Lead and facilitate initial and periodic training of QC Technicians and Analysts to ensure standard adherence to laboratory practices, techniques, and adherence to cGxP and other applicable regulations and standards
• Interact with auditors/clients during visits and tours
• Prepare and perform personnel evaluations and competencies and administer performance reviews.

Requirements:

• Bachelor’s Degree in Biology, Chemistry or Life Sciences
• 5+ years in QC release testing or similar experience
• Clinical laboratory experience preferred
• Knowledge of GxP regulations in a cGxP environment
• Knowledge of raw materials sampling techniques and of sampling plans
• Strong organizational skills to be able to manage multiple tasks simultaneously, and the ability to appropriately prioritize tasks
• Strong attention to detail in order 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
• Direct supervisory experience strongly preferred

Physical Demands:

• Some processes entail repetitive motion and extended periods of time in a standing position

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.

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