Quality Assurance Specialist

📋 Description

• • At Foresight Diagnostics, now a part of Natera, quality is not merely a final inspection; it is an intrinsic element embedded within every facet of our operations. Our mission is to pioneer non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies, and the integrity of our MRD cancer detection platform is paramount. We are seeking a dedicated Quality Assurance Specialist to become a cornerstone of this commitment, a professional who possesses an unwavering attention to detail and a profound understanding of the critical impact these details have on patient outcomes.
• • As a Quality Assurance Specialist, you will be instrumental in upholding and strengthening our robust Quality Management System (QMS), which serves as the essential framework for clinical compliance across both our laboratory and product development endeavors. In an environment of rapid growth and scaling operations, your role is vital in ensuring this foundational system remains resilient and effective. You will actively contribute to the investigation and resolution of quality events, meticulously manage documentation processes, empower cross-functional teams with quality insights, and play a key role in building and refining our quality infrastructure to support our expanding needs.
• • This is a hands-on position offering direct influence over the operational efficiency and compliance confidence of our organization within a highly regulated clinical landscape. You will be deeply integrated into the daily workflows of our QMS, fostering close partnerships with Laboratory Operations, process development teams, and a diverse range of cross-functional stakeholders. Your responsibilities will encompass a broad spectrum of critical QA functions:
• • **Non-Conformance and Corrective/Preventive Action (NCR/CAPA) Management:** You will provide comprehensive support for the entire lifecycle of NCR/CAPA processes, from initial investigation and thorough root cause analysis to the effective implementation and closure of corrective actions. This ensures that all quality deviations are meticulously documented, their underlying causes are fully understood, and preventive measures are robustly established.
• • **Document Management and Control:** You will expertly manage all document control functions within our electronic QMS (eQMS) platform. This includes coordinating document change orders, facilitating the rigorous review and approval processes, and ensuring adherence to all applicable regulations and Standard Operating Procedures (SOPs) for document retention and accessibility.
• • **Laboratory Operations Support:** You will offer direct Quality Assurance support to our Laboratory Operations teams, ensuring that daily laboratory processes consistently meet compliance standards and actively contribute to a culture of continuous improvement.
• • **Training Program Oversight:** You will take ownership of the document control and training programs, guaranteeing the complete lifecycle management of all training materials, maintaining audit readiness, and ensuring adherence to role-based training requirements across the entire organization.
• • **Change Management Facilitation:** You will support change management activities across various cross-functional teams, ensuring that all proposed changes are systematically assessed for their impact, thoroughly documented, and implemented in a controlled and compliant manner.
• • **Internal Auditing:** You will conduct comprehensive internal audits designed to evaluate the effectiveness of our QMS, identify areas of non-compliance, and pinpoint opportunities for significant process improvements.
• • **SOP Development and Revision:** You will be responsible for developing new SOPs and revising existing ones to accurately reflect current operational practices and evolving regulatory requirements, thereby promoting clarity, consistency, and standardization throughout the organization.
• • **Process Improvement and Tool Implementation:** You will actively evaluate and implement new tools, systems, and methodologies aimed at enhancing laboratory process efficiency and ensuring consistent conformance to quality standards.
• • **New Product and Process Support:** You will contribute to the identification and support of quality test methods, establish clear inspection criteria, and conduct thorough risk assessments for all new products and processes introduced by the company.
• • **Supplier Quality and Compliance:** You will provide support for supplier approval processes and assist with other laboratory quality compliance initiatives as required, ensuring that our external partnerships meet our high standards.
• • This role is crucial for maintaining the high standards of our diagnostic platform, directly impacting the reliability and trustworthiness of the cancer detection results that clinicians depend on. You will be an integral part of a Quality team that is proactively building a culture of excellence, operating from Boulder, Colorado – a city renowned for its exceptional outdoor lifestyle and thriving biotech talent pool.
• • Foresight Diagnostics is committed to fostering internal growth. We actively promote from within, seeking to develop and advance individuals who demonstrate exceptional performance and a dedication to quality. If you aspire to work in an environment where quality is not just a departmental function but a deeply ingrained organizational mindset, this is the ideal opportunity for you.