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Labcorp Quality Assurance Project Analyst -- Microbiology in Raritan, New Jersey

The Project Analyst is responsible for promoting a culture of quality in the Microbiology department through communication and increased quality awareness. This person ensures that the Quality programs, systems, processes, and procedures, and the performance and quality of services, conform to established regulatory and accreditation (CLIA, CAP, NYS, ISO 15189) requirements for this department. Acts in a proactive manner in the identification and rapid resolution of critical issues which adversely affect quality. Provides leadership for quality programs including the implementation of policies and systems which lead to continuous quality improvement.

Job Duties/Responsibilities

  • Assigns, oversees and reviews all phases of quality for the Microbiology department

  • Coordinates the effort with divisional QA to maintain LabCorp's quality assurance program

  • Works with the Technical Director on oversight of the proficiency testing program; tracks external and internal proficiency testing & ensures that PTF error responses are complete

  • Conducts internal audits and ensures corrective actions are implemented and followed

  • Tracks and documents various quality reports and provides documentation to leadership

  • Observes and helps to maintain operational efficiency while ensuring regulatory compliance

  • Collects summary data for the departmental QA Committee reports regarding quality indicators

  • Works with the Technical Director to develop quality goals and objectives for the department

  • Coordinates all validations and end-to-end testing, and assists in the analysis of data and writing of validation reports

  • Mentors direct reports; quality coordinator and/or quality analyst employees

  • Ensures that personnel training and competency assessment records are complete

  • Reviews quality control data and patient result trending

  • Provides guidance in implementing policies with respect to regulatory & accreditation requirements

  • Ensures the department maintains a regulatory readiness at all times

  • Monitors and documents calibrations of tools used to complete testing

  • Ensures general and technical SOPs and policies are current and all relevant employees are trained

  • Documents and reports trends such as failing processes and corrective actions.

  • Performs internal audits to ensure compliance and identify opportunities for improvement

  • Investigates and formulates responses to customer or regulatory agency citations or complaints

  • Reviews current regulatory standards to ensure all legal standards are met

  • Maintains Master Control documents such as SOPs, non-conformance documents and QC failures

  • Responsible for notifying employees of new changes to regulations and/or policies

  • Prepares and leads the monthly departmental QA meeting; records minutes/updates/reports etc.

  • Meets with departmental staff to discuss quality matters on a monthly basis

  • Represents the department at monthly Quality Management meetings

Requirements

  • Bachelor's degree in Medical Technology or a Life Science

  • Minimum of 6 years of technical experience in a clinical laboratory environment is required

  • Previous experience working in Microbiology is highly preferred

  • Prior experience in a quality related position is a plus

  • Strong working knowledge of laboratory regulations (CAP/CLIA/NYS/ISO 15189) and licensing requirements

  • Must be familiar with QC rules and their application within the laboratory

  • General understanding of audit related requirements and procedures

  • Working knowledge of quality assurance/quality management best practices

  • Must possess excellent analytical, critical thinking, problem solving, and communication skills

  • Familiar with formatting procedures and other documents in document control software

  • Proficient in MS Office (Word, Excel, Access, PowerPoint)

  • Experience with Crystal Reports, Master Control and EP Evaluator software is a plus

  • Ability to work independently and within a team environment

  • Well organized and ability to meet deadlines

  • High level of attention to detail

Shift

1

Schedule

Monday - Friday (8:30am - 5:00pm)

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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