Senior Quality Lab SpecialistBedford, MAROLE SUMMARY:We are looking for a skilled and experienced Senior Quality Lab Specialist to join our Quality team in Bedford, MA. The Senior Quality Lab Specialist will ensure regulatory compliance, lead audits, and drive continuous improvement of our Quality Management System. This position will be onsite for training and has the potential to work a hybrid schedule.
WHAT YOU'LL DO:- Responsible for establishing and maintaining a culture of trust and compliance with established Quality standards
- Participation on cross functional project teams to provide guidance to meet the Accelerator QMS.
- Ensure Accelerator Laboratory Service's compliance with CLIA regulations, ISO15189, and GCLP guidelines through the assessment of established Quality Systems and education and training of laboratory staff in Quality Principles
- Oversee Internal Sample Tracer audits and other audits as needed
- Provide QA review support of SOPs, validation protocols and reports, deviations, and CAPAs
- Prepare and present quality audit reports for management
- Assist in administering an internal proficiency testing program
- Lead efforts to continuously improve existing Quality Management System
BASIC QUALIFICATIONS:- Bachelors Degree in life sciences (Medical Technology, Chemistry, Biology or biomedical engineering)
- 5+ years of experience in a Quality role supporting a regulated medical device, IVD, or pharmaceutical company QMS
PREFERRED QUALIFICATIONS:- 3+ years of experience in a Quality role supporting CLIA, ISO 15189, or GCLP
- Experience conducting Quality audits
WHY YOU'LL LIKE WORKING WITH US:Our Technology:
From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Akoya Biosciences, a Quanterix company, is The Spatial Biology Company®-bringing tissue context to life through high-resolution, single-cell imaging. Akoya's spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler®, PhenoImager® Fusion and HT, and PhenoCode™ Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.
Our Commitment to Employees:At Quanterix, our values are based on:
Team,
Innovation, Customer and Owner.
Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards
Innovation: Stay curious, experiment, create and change
Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments
Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.
We reward and recognize our employees by offering competitive compensation and a 401k plan with 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 eligible for equity, 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!
DIVERSE & INCLUSIVE WORKPLACE:Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Pay Range: $100,000 - $120,000 per year
