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Senior Quality Assurance Specialist

Organization

Foresight Diagnostics

Job Location

12705 E. Montview Blvd.
Aurora, CO 80045
United States

Salary

91,000 - 108,000

Benefits

Medical, Dental and Vision

Job Description

About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Aurora, Colorado.

About the Role: The Senior QA Specialist will support laboratory quality compliance processes, and help to develop and implement the Quality Management System (QMS) to ensure adherence to CAP/CLIA, FDA GMP, and ISO 13485 regulations. The Senior QA Specialist will also be tasked with supporting the development of quality processes, investigating quality issues, and implementing continuous improvement activities to ensure that processes are scalable while maintaining Quality standards.

What You Will Bring:

Bachelor’s degree in life sciences or related technical field
Minimum of 2 years of Quality experience in a regulated environment
Knowledge of Quality System requirements, including ISO13485 and 21CFR820, and CAP/CLIA clinical regulations
Experience conducting Quality Assurance functions across investigations (NCR, CAPA), internal audits, release and reporting of results, SOP review and approval, document control, and risk management
Attention to detail with a strong ability to create and review technical documentation
Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing
Ability to work independently, and utilize good problem-solving skills
Ability to multitask and work within a fast-paced dynamic team environment

What You Will Do:

Support the management of NCR/CAPA, laboratory support, supplier approvals, document control, training, internal audits, and other QMS responsibilities
Provide direct QA support to Laboratory Operations and process development
Review and approve batch records for product release
Ensure the Quality System elements are in compliance with the regulations, and help to create and/or drive improvements in the creation of Standard Operating Procedures
Provide QA support to create and maintain the laboratory process in a validated state
May support other lab-related activities including: materials receipt/transfer/release, labeling verification, QC report review, etc.
Develops, implements, and evaluates tools, systems, and methods for laboratory process improvement and conformance
Identifies and supports quality test methods, inspection criteria, risk assessments, and other processes for new products to ensure compliance to regulatory standards
Perform other duties as assigned by supervisor

About Our Organization

Foresight Diagnostics is a cancer diagnostics company developing a novel liquid biopsy test for the measurement of minimal residual disease (MRD) for aid in patient management that is funded by leading diagnostics VC firms in Silicon Valley. Foresight’s cell-free DNA testing platform was developed in the labs of two prominent professors at Stanford University and is backed by several major Cell and Nature publications. The company has garnered significant partnering interest from multiple pharmaceutical companies in oncology and is poised for rapid growth. Foresight Diagnostics is headquartered in Aurora, Colorado.