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QualityAssurance Analyst
This is an exciting opportunity to join a leading PCR lab, servicing over 15k clients nationwide. The QA Analyst will be part of the QA department and participate on planning, implementing, and monitoring the Quality Management System (QMS). This role will be responsible for ensuring that the lab meets quality and productivity standards and complies with all safety and regulatory as defined by CAP, JCAHO, OSHA and CLIA.
Responsibilities:
- Maintain procedure manuals, training records, validation documents, personnel records, quality documentation, etc. to ensure regulatory preparedness at all times; adhere to regulatory standards.
- Maintain procedure manuals in applicable areas of the lab.
- Participate in lab audits and accreditation inspections as requested by management.
- Acts as a liaison between all departments in the lab and the QA department to answer quality-related questions, implement policies/procedures, and enforce quality objectives.
- Ensure Doc Control System maintains the integrity and standards set by QA management.
- Execute minor changes to controlled documents (as requested) in the Doc Control System.
- Ensure that all equipment, machines, or instruments are maintained, inspected, and calibrated.
- Keep records of applicable service and maintenance agreements as well as logs, as applicable.
- Execute verification of lab documentation (i.e. temperature/humidity monitoring, various logs, etc.) on a routine basis established by the QA department.
- Maintain knowledge of proper specimen collection procedures, including patient preparation, labeling, handling, preservation, processing, preparation, transportation, and storage of specimens.
- Obtain QA documentation and data to assist in the creation of monthly/annual Quality Reports; establish effective systems to monitor accuracy assessments and data quality throughout the lab.
- Manage laboratory staff contact information
- Conduct QA procedures to monitor core performance and notifies QA management and area supervisor of performance issues as they develop; work with area supervisor to establish a remediation plan.
- Provide training to new hires and current staff as needed.
- Maintain licensures as applicable and participate in continuing education
- Act as a member of the Safety and QA/PI Committee; attend meetings and implement changes, as needed:
- Participate with QA department in overseeing all clinical laboratory departments in a manner conducive to optimal performance and high morale;
- Pull monthly QA data and follow through on issues report in a timely manner
- Follow lab’s procedures for specimen handling and processing, test analyses, reporting, and maintaining records of patient test results; and
- Review and maintain records of maintenance
- Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
Requirements and Desired Experience:
- Bachelor’s degree, required
- 2 years prior clinical laboratory experience preferred
- Able to perform, create, and interpret statistical data for validations, correlations, etc.
- Able to quickly learn proprietary software programs like LIS, Media Lab, Asana, etc.
- Able to create and present presentations to small and large groups
- Able to create and work with statistical data
- Experience with Microsoft Office suite; Excel, Word, PowerPoint, etc.
- Excellent verbal and written communication skills
- Willing and able to travel occasionally (less than 10%)
Compensation: $60k - $70k annual salary
