Quality Assurance Technician
Summary of Major Responsibilities
The Clinical Laboratory Quality Assurance (QA) Technician is responsible for many quality aspects in the clinical laboratory, including supporting and maintaining the quality management system, facilitating feedback monitoring and resolution for customer satisfaction, and non-conforming event management. The QA Technician will participate in, and facilitate process improvement, process change, and coordination of user awareness within the laboratory departments
Essential Duties and Responsibilities
- Quality Systems & Quality Management (QM) Process: assists in maintaining clinical laboratory QA plans, policies, processes and procedures in accordance with federal and state guidelines.
- Coordinate Change Control: facilitates process improvement amongst laboratory departments
- Assess Changes: measures process changes to determine impact on adjacent processes and departments
- Facilitates Awareness: participates in departmental process changes, and brings visibility of changes to appropriate leadership
- Non-conforming event management: participate in review and documentation of non-conforming events, supports investigations, root cause analysis, and development of corrective and preventive actions.
- Feedback and Resolution: provides assessment, quality input and guidance, investigational support, and resolution for end-user feedback, interacts with representative from the Customer Care Center for follow up; assists in gathering documentation to support feedback escalations.
- Other Duties as necessary (i.e., assist in gap analysis, risk management, document control, audits, inspections, cross-departmental metrics or information, etc.).
Mandatory Skills & Qualifications:
- Exceptional written and verbal communication skills with strong attention to detail, organization, and record-keeping skills.
- Proficient skill in Excel or similar software for metrics generation.
- Demonstrated ability to collaborate across functions and with both internal and external stakeholders, and to communicate ideas and opinions in a proactive and professional manner.
- Has a working knowledge of FDA, CLIA, and CAP.
Necessary Education & Experience:
- Associate’s degree, or equivalent
- Preferred experience in a laboratory-based environment or quality systems
- Previous experience with quality management systems or certifications in quality assurance preferred.
- Demonstrated understanding of specific state regulatory requirements for clinical laboratory operations such as CA, NY, MD or FL.
- Direct experience working with a Laboratory Information System, and past experience with HIPAA regulations.
- Direct experience working with change control processes and document control processes
Physical Requirements & Working Conditions:
- Position requires work in normal office environment.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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