Senior Document Control Specialist, Batch Records

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.

We are looking for an experienced and highly motivated Senior Document Control Specialist, Batch Records to join our Quality Assurance team. This individual will support Quality Assurance in the Document Control Department by assisting in the review of batch records, processing of controlled documents and training materials.  Additional responsible includes archiving and filing the final batch records and other company records, and providing lot numbers to support the Manufacturing Team.

What You’ll Do:

• Responsible for review and approval of executed batch records
• Support daily operations including processing of controlled documentation in Electronic Management system
• Support/drive revisions including process improvements of Document Control procedures
• Support daily operations including creating and maintaining training job codes and Training assignments
• Responsible for exam revisions and publishing of Training materials in the Electronic Management system.
• Supports scanning and uploading of Quality documents
• Marking documents for corrections and interfacing with Manufacturing/QC to implement corrections
• Performing kit lot releases and posting assay documentation on the website
• Issuing, reviewing, and closing batch record-related deviations
• Supporting metric reporting
• Issuance of lot numbers and labels
• Filing batch records and maintaining physical/electronic archives
• Filing general records and preparing inventory for offsite storage

What We’ll Expect From You: 

• Bachelor's degree in Science, Medical Technology, English, or Technical Communications preferred
• 4+ years of Quality Assurance and/or batch record experience in a ISO 13485 QMS
• 2 years of Document Control and Training experience preferred
• Demonstrate excellent verbal and written communications
• Must be organized and have the ability to multitask
• Solid work ethic and superior attention to detail
• Demonstrate strength working independently
• Teamwork and the ability to work effectively across functional teams ensuring requirements are met
• Skilled in organization, decision-making, and building strong business relationships

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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