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Senior Quality Assurance Associate/QA Manager [Ref 267722] - Waltham, MA

Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. Exosomes are messengers released by all living cells into biofluids, such as plasma/serum, urine, cerebrospinal fluid and saliva, forming a highly enriched source of RNA, DNA and proteins from their cell of origin. Our proprietary exosome-based technology platform can yield comprehensive and dynamic molecular insights about cells in the body without direct access to the actual cells. Through this novel technology, we are focused on transforming how cancer and other serious diseases are detected, diagnosed, treated and monitored. In 2016, we launched multiple diagnostics, including liquid biopsy tests for lung, prostate and other solid tumor cancers. In 2017, we will be launching new diagnostic tests and a exosome detection platform.

As we are advancing our commercial operations, we are seeking a Senior Quality Assurance Associate / Quality Assurance Manager for our CLIA lab in our Cambridge headquarters to help us with our rapid growth. The QA Manager will be responsible for the operation and administration of the CLIA Quality Management System used by the Cambridge Lab of Exosome Diagnostics (ExoDx).

• Minimum: Bachelor's degree in biological sciences including molecular biology.
• 3-5 years of experience working in a regulated, high complexity testing CLIA laboratory environment
• Experience and knowledge of clinical laboratory testing requirements (CLIA and NYS DPH regulations)
• CLIA laboratory experience required
• Experience with pharma CRO services desired
• Familiarity with LIMS and electronic Quality Management System Software desired.

Key Responsibilities:
• Responsible for the operation and administration of the CLIA QMS and assuring compliance with applicable regulations (CLIA, NYS DPH)
• Responsible for quality management of CLIA assays and the laboratory
• Work closely with the relevant stakeholders to maintain the CLIA Management System
• Manage the electronic Document Control System for CLIA documents
• Manage the electronic Corrective and Preventive Action (CAPA) system for CLIA issues
• Maintain CLIA compliance records, including audit and inspection, vendor approval, proficiency testing reports, and personnel training
• Maintain documentation for compliance , including but not limited to CAPA, change controls, investigations, and deviations
• Perform or facilitate internal audits
• Manage internal and external CLIA audit commitments, to ensure compliance
• Maintain, analyze, and develop metrics for key quality indicators for the CLIA lab
• Other duties as assigned

What we offer:
• Competitive salary/ benefits package and an attractive location in the vibrant Boston/Waltham community of biotech and academic research.
• Opportunities to enhance your career with an emerging organization poised for significant growth.

How to apply:
Interested candidates should submit a resume (Word or PDF format) to Please put [267722] Senior Quality Assurance Associate/QA Manager in the subject line. No phone calls and no agencies, please!