Job Overview
Location
Cambridge
Job Type
Full-time
Category
Other
Date Posted
May 23, 2026
Full Job Description
đź“‹ Description
- • Assist in the quality assurance of molecular sampling kits and rapid diagnostic products used for genome and microbiome analysis and infectious disease detection.
- • Perform routine inspections and testing of raw materials, in-process components, and finished goods to ensure compliance with internal specifications and regulatory standards.
- • Document and maintain accurate quality control records, including batch records, test results, and deviation reports, in accordance with FDA and ISO quality system requirements.
- • Collaborate with production and engineering teams to investigate and resolve quality issues, root cause analyses, and corrective and preventive actions (CAPAs).
- • Support internal and external audits by preparing documentation, coordinating site access, and ensuring audit readiness across manufacturing and laboratory operations.
- • Follow standard operating procedures (SOPs) for all quality-related activities and contribute to the continuous improvement of quality processes and documentation.
- • Use laboratory equipment and instrumentation to conduct physical, chemical, and biological testing as required for product release and validation.
- • Participate in the review and revision of quality documentation, including test methods, specifications, and quality control plans.
- • Ensure all quality activities align with Good Manufacturing Practices (GMP) and other applicable regulatory guidelines.
- • Report quality trends and anomalies to supervisors and contribute to monthly quality performance reviews.
- • Maintain a clean, organized, and compliant work environment in accordance with laboratory and manufacturing safety protocols.
- • Support new product introductions by participating in process validation, qualification, and transfer activities.
- • Communicate effectively with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain to ensure product quality objectives are met.
- • Stay current with evolving regulatory requirements and industry best practices in diagnostics and molecular testing.
- • Perform other quality-related duties as assigned by management to support company goals and operational needs.
🎯 Requirements
- • Bachelor’s degree in Biology, Chemistry, Microbiology, or a related scientific field
- • Experience working in a GMP-regulated manufacturing or laboratory environment
- • Familiarity with FDA and ISO quality system regulations
🏖️ Benefits
- • Health insurance coverage
- • Paid time off and holidays
- • Professional development opportunities
Skills & Technologies
About DNA Genotek Inc.
DNA Genotek Inc. develops and manufactures biological sample collection, stabilization and preparation products for genetic testing and research. Its Oragene, OMNIgene, and Performagene kits enable non-invasive self-collection of saliva, blood, fecal, skin and environmental samples while preserving nucleic acids at ambient temperature. The company serves academic, clinical, pharmaceutical, livestock and consumer genomics markets worldwide, supporting applications such as pharmacogenomics, infectious disease surveillance, microbiome studies and personalized medicine. Founded in 1998 and headquartered in Ottawa, Ontario, Canada, DNA Genotek operates as a subsidiary of OraSure Technologies, Inc. since 2011.
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