Our mission at Progenity is simple: to help healthcare providers and patients prepare for life. We provide the most advanced molecular technology and the highest levels of service to guide patient care at critical life stages. We continually seek people with the motivation and skills to advance our mission.
The Quality Associate serves as a member of Progenity’s Quality Management team, whose focus is on supporting quality processes required by CLIA, CAP, NYS and other state and local requirements to ensure quality of patient test results in collaboration with the laboratory medicine and operations teams.
RESPONSIBILITIES:
- Participates in tracking and compiling, Quality Systems data/metrics to meet the needs of organizational leadership.
- Identifies and supports improvements for clinical laboratory testing and supporting processes.
- Maintains effective working relationships and communication within department and cross-functionally.
- Communicates needs effectively to facilitate development of tools needed for monitoring, as well as other processes.
- Assists with coordination and review of proficiency testing.
- Assists in performing root cause analysis and establishing Corrective and Preventative Actions (CAPAs).
- Participates in internal audits and mock laboratory inspections.
- Assists in the documentation of laboratory staff training.
- Assists with document control and records management.
- Participates in training programs to facilitate the proper use and implementation of quality systems.
- Represents department and the organization favorably and in accordance with established Company standards.
- Follows all company safety policies & other safety precautions within the work area.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS:
- 0-2 years’ experience in a clinical molecular diagnostics lab with knowledge of CLIA, CAP and state requirements.
- Document Control, CAPA, and Audit experience is a plus.
- Experience reviewing clinical molecular results for quality assurance.
- Experience in molecular methods and NGS (next generation sequencing) and ELISA preferred.
- Experience with electronic Quality Management Systems (eQMS) preferred.
- Proficient in Microsoft Office, specifically, Word, Excel, and PowerPoint.
- Extremely detail oriented and committed to high Quality.
- Excellent communication, interpersonal, and analytical skills with all levels.
- Experience working in a fast-paced laboratory environment.
- Proficient in Microsoft Office, specifically, Word, Excel, and PowerPoint.
- Some statistical skills and knowledge preferred.
- Ability to travel approximately 10%, including overnight visits.