Job Description

To continue our solid growth, we are seeking a talented and highly motivated Document Control Specialist (Batch Records) to join our growing organization.  This position will be part of our Quality Assurance team.  The Document Control Specialist will be responsible for maintaining and coordinating review and processing of internal documents in the electronic document control system. In addition, they will be responsible for providing numbers for Quality Assurance documents [CAPA's, Change Controls], supporting exam development for training and regularly reporting on training progress on new and revised documents. This individual will also be responsible for assisting in the writing and editing of technical documents for our growing product portfolio.  The individual will also be the primary contact with users of the electronic document management system.

KEY RESPONSIBILITIES:

 Support training and exam creation for SOPs in Master Control, including maintaining associated metrics.

• Issue Change Control and CAPA numbers.
• Support creation of and update to product labels and creation of part numbers, per defined processes.
• Coordinate the flow of IQ/OQ document approvals and outside supplier documentation.
• Assisting the Technical Writers in writing, editing and processing customer facing and Quanterix Service team documents as necessary to support the development and launch of the instrument and assay product lines. 
• Serve as a back-up system administrator for Master Control.
• Serve as a back-up reviewer for batch records, ensuring integrity and that evaluations are within specifications.
• Support QA organization as necessary, including assisting with audits, procedure development, etc, as defined by the Quality Assurance leadership.

 SKILL AND KNOWLEDGE REQUIREMENTS:

• Excellent organizational and communication skills.
• Solid work ethic and a superior attention to detail.
• Excellent written and editorial skills.
• Demonstrated strength working independently.
• Excellent team player with strong interpersonal skills.
• Experience with Master Control strongly preferred.
• Experience working in a regulated environment (ISO, GLP, GMP, FDA) strongly preferred.
• Motivation to critically review own work before sending out for review.
• Fluent in word processing and good working knowledge of Word, Excel, and other software programs.
• Comfortable working in a fast-paced environment, balancing multiple projects, and keeping to tight deadlines.

MINIMUM EXPERIENCE AND EDUCATION:

• Bachelor's degree in Science, Medical Technology, English, or Technical Communications.
• 2 years of Quality Assurance, Document Review, and/or Technical Writing experience.

PHYSICAL DEMANDS:

• General office requirements, no heavy lifting required.

TRAVEL REQUIREMENTS:

• Very limited; <5% of time.

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.