To continue our solid growth, we are seeking a talented and highly motivated Quality Control Supervisor, Raw materials/Inspection to join our growing organization. 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 and raw materials testing.
This role will be expected to:
- Oversee team of 3+ QC technicians through effective planning, mentoring, directing and coordination of development activity.
- Oversee the scheduling of raw material testing, finished goods inspection, and release 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 13485 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
- Interact with auditors/clients during visits and tours.
- Prepare and perform personnel evaluations and competencies and administer performance reviews.
Skill and Knowledge Requirements:
- 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.
Minimum Experience and Education:
- 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
- Some processes entail repetitive motion and extended periods of time in a standing position
Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. 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, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.
Quanterix is committed to a diverse and inclusive workplace. Quanterix is an equal opportunity employer and does not discriminate on the basis of 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.