Quality Assurance Analyst II

JOB DESCRIPTION

Quality Assurance Analyst II

Department: Lab Support

FLSA Status: Exempt

Reports To: Director of Quality

Manages People: No

Experience: Typically requires 2-4 years of related experience

Level of Supervision: Work is generally independent

Job Summary:

• The QA Analyst is a supportive role within the QA department that assists with planning, implementing, and monitoring the Quality Management System (QMS). The QA Analyst is responsible for ensuring that the laboratory meets quality and productivity standards and complies with all regulatory and safety standards as defined by CAP, JCAHO, CLIA and OSHA.

Essential Responsibilities/Duties:

• Ensures regulatory preparedness at all times by maintaining procedure manuals, training records, validation documents, personnel records, quality documentation, etc. while adhering to CAP, CLIA, and OSHA standards.

• Maintain procedural manuals in applicable areas of the laboratory.

• Participates in laboratory audits and accreditation inspections, at the capacity requested by QA management.

• Acts as a liaison between all departments in the laboratory (including Pre-Analytic, Analytic, and Post-Analytic) and the QA department to answer quality-related questions, implement policies/procedures, and enforce quality objectives.

• Ensures the Document Control System maintains the integrity and organizational standards set by QA management.

• Executes minor changes to controlled documents (as requested) in the Document Control System.

• Ensures that all equipment, machines, or instruments are maintained, inspected, and calibrated.

• Keeps records of applicable service and maintenance agreements as well as logs, as applicable.

• Executes verification of laboratory documentation (e.g., temperature/humidity monitoring, various logs, etc.) on a routine basis established by the QA department.

• Maintains knowledge of proper specimen collection procedures, including patient preparation, labeling, handling, preservation, processing, preparation, transportation, and storage of specimens.

• Obtains QA documentation and data to assist in the creation of monthly/annual Quality Reports, as well as establish effective systems to monitor accuracy assessments and data quality throughout the laboratory.

• Manages laboratory staff contact information

• Conducts QA procedures to monitor core performance and notifies QA management and area supervisor of performance issues as the issues develop, and work with the area supervisor to establish a remediation plan.

• Provides orientation/training to all new hires as well as current staff, as needed.

• Participates on subspecialty committees, corporate committees, and regional committees as needed.

• Accepts responsibilities delegated from the QA Supervisor or Director (the QA Supervisor or Director is permitted to delegate responsibilities to the QA Analyst, if the QA Analyst is qualified to perform the responsibility);

• Maintains licensures as applicable and participates in continuing education; ensure staffing does the same.

• Acts as a member of the Safety and QA/PI Committee, attend meetings and implement changes, as needed:

o Participates as a member of other committees, as assigned.

o Pulls monthly QA data and follow through on issues report in a timely manner.

o Reviews and maintains records of maintenance.

o Participates with the QA department in overseeing all clinical laboratory departments in a manner conducive to optimal performance and high morale;

o Follows the laboratory's procedures for specimen handling and processing, test analyses, reporting, and maintaining records of patient test results; and

o Maintains records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.

COLLABORATIVE DUTIES:

• Inspection/Audits/Surveys:

o Coordinates pre-inspection evaluations, post-inspection responses, and interimself inspections with laboratory management and staff. The expectation is the laboratory be prepared and operates on a day-to-day basis to result in no deficiencies on any scheduled, random, or unannounced inspection from any accrediting agency including but not limited to CLIA, CAP, OSHA, Department of Health, State, etc.

• Quality/Safety Program:

o Acts as or works with the QA and Safety Supervisor; attends Committee meetings to implement changes as needed.

o Leads and/or assists in the development/ongoing continuous quality management for the laboratory.

o Reviews monthly metrics and assists in corrective action/procedural changes to maintain "green light" status per desired/required goal.

o Participates in the local and national quality/safety committee meetings, as requested.

o Assists in preparing the annual laboratory quality assessment plan that is evaluated for its effectiveness and assembles new initiatives planned by Laboratory Director, Partner Laboratory Quality and Compliance Director, Laboratory Management, and Quality Committee members; and

o Works with IT to develop programs to automatically collect and collate data for the committee.

• Process Improvement/Implementation:

o Evaluates and assists with lean projects in the laboratory that works to improve overall processes to help the company provide quality care in a cost effective and timely manner to its patients.

Qualifications:

• Education -

Bachelor's degree, required

• Competencies/Skills -

Excellent verbal and written communication skills

Ability to create and present presentations to small and large groups

Basic math skills: Ability to create and work with statistical data

Moderate to advanced skill level in Microsoft Office Products (Excel, Word, PowerPoint, etc.) and Adobe Acrobat

Ability to perform, create, and interpret statistical data for validations, correlations, etc.

Ability to quickly learn proprietary software programs (e.g. LIS, Media Lab, Asana, etc.).

Ability to travel <10% of time

Experience -

2 years prior clinical laboratory experience, preferred

Certifications/Licenses -

N/A