Job Description
ABOUT US:
THE TESTING CENTERS OF AMERICA, A $2 BILLION MOLECULAR TESTING CENTER, IS SEEKING A HIGHLY MOTIVATED QUALITY AND COMPLIANCE MANAGER WITH THE DRIVE TO PUT AMERICA SAFELY BACK TO WORK AND RESTORE THE ECONOMY OF THE UNITED STATES OF AMERICA. IN THIS TIME OF URGENT NEED, TCA IS SCALING UP TO BRING HUNDREDS OF THOUSANDS OF COVID-19 TESTS NATIONWIDE TO SUPPORT OUR GOVERNMENT’S EFFORTS TO ENSURE AMERICANS RETURN TO THEIR JOBS IN A SAFE WORKING ENVIRONMENT. COME WORK FOR THE FASTEST GROWING HEALTHCARE COMPANY IN THE UNITED STATES AND HELP AMERICA GET BACK TO WORK.
TCA’S CENTER OF EXCELLENCE PROVIDES DIAGNOSTIC AND ANTIBODY TESTING ON CORONAVIRUS SAMPLES TO HELP MITIGATE AND END THE EFFECTS OF THE GLOBAL PANDEMIC. WE WILL FOSTER HEALTHCARE AND PUBLIC HEALTH POLICY WITH TESTING AND DATA STUDIES CRITICAL TO INDUSTRY, ACADEMIC INSTITUTIONS, AND GOVERNMENT CLIENTS, AND LARGE-SCALE POPULATIONS. THE QUALITY AND COMPLIANCE MANAGER WILL BE AN INTEGRAL PART OF OUR MISSION TO PROVIDE ALL AMERICANS AND AMERICAN BUSINESSES THE ABILITY TO OPERATE IN SAFE WORK ENVIRONMENTS.
TCA IS SEEKING A ROCKSTAR TEAM OF INNOVATIVE, RESILIENT, INTELLIGENT, ADAPTABLE, AND COMPASSIONATE PEOPLE THAT ARE INSPIRED BY MAKING A DIFFERENCE! WE WANT YOU TO COME JOIN US, SO WE CAN MAKE THIS DIFFERENCE TOGETHER!
THE DIFFERENCE-MAKING ROLE: QUALITY AND COMPLIANCE MANAGER
JOB SUMMARY: THE QUALITY AND COMPLIANCE MANAGER IS RESPONSIBLE FOR INTERNAL REGULATORY COMPLIANCE RELEVANT TO TCA LABS OPERATIONS AS WELL AS THE MANAGEMENT OF COMPLIANCE-RELATED ACTIVITIES. THE PRIMARY RESPONSIBILITY OF THE QUALITY AND COMPLIANCE MANAGER IS THE MONITORING, MEASUREMENT, AND REVIEW OF INTERNAL PROCESSES AND PROCEDURES, ESPECIALLY THOSE THAT AFFECT THE QUALITY OF THE TCA’S SERVICES .
KEY RESPONSIBILITIES:
DAILY OVERSIGHT OF LABORATORY QA/QC PROCESSES; MUST ENSURE QA/QC PROCESSES AND RESOURCES CAN ACCOMMODATE PROJECTED VOLUME/SCALE.
DEVELOPMENT AND REPORTING OF KEY PERFORMANCE METRICS TO BE UTILIZED IN CONTINUOUS IMPROVEMENT EFFORTS
ANALYZE AND RECOMMEND PERFORMANCE IMPROVEMENT STRATEGIES AND PLANS OF CORRECTION BASED UPON DEFICIENCY/LAB REPORTING TRENDS AND PROACTIVE IMPLEMENTATION OF PERFORMANCE IMPROVEMENT STRATEGIES TO MITIGATE RISK AND NONCOMPLIANCE
ENSURE ALL COMPETENCY TRAINING IS COMPLETED AS REQUIRED; PROVIDE ONGOING FEEDBACK TO ENSURE STAFF COMPETENCIES AND DEVELOPMENT.
CREATE INCIDENT REPORTS, CONDUCT ROOT CAUSE ANALYSIS; SUGGEST IMPROVEMENT PLANS, WORK WITH LAB LEADERSHIP TO IMPLEMENT SOLUTIONS
ASSIST IN THE DEVELOPMENT, ROLLOUT AND ONGOING MONITORING OF CLIENT SATISFACTION
POLICY, PROCEDURE AND PROTOCOL GOVERNANCE FOR LABORATORY SITE
COORDINATE ALL FACILITY AUDITS OF TCA LABS BY OUTSIDE AGENCIES AND CLIENTS, MEET REGULATORY REQUIREMENTS, INCLUDING BUT NOT LIMITED TO COLLEGE OF AMERICAN PATHOLOGISTS (CAP)
DEVELOP AND MONITOR ALL PLANS OF CORRECTION WHETHER THEY ARE GENERATED FROM AN EXTERNAL MONITORING AGENCY OR FROM INTERNAL MONITORING CONDUCTED BY THE COMPLIANCE TEAM AND/OR QUALITY TEAM
MANAGE AND DOCUMENT ALL TRAINING/CONTINUING EDUCATION ACTIVITIES
QUALIFICATIONS:
M.S. IN CLINICAL OR FORENSIC LABORATORY SCIENCE, CHEMICAL, PHYSICAL, OR BIOLOGICAL SCIENCE OR IN QUALITY ASSURANCE/REGULATORY AFFAIRS.
3+ YRS BIOANALYTICAL OR REGULATED LABORATORY EXPERIENCE.
3+ YRS EXPERIENCE IN A MANAGEMENT CAPACITY
3+ YEARS EXPERIENCE MANAGING TEAMS; ABILITY TO THRIVE IN A MATRIX ENVIRONMENT.
TECHNICAL WRITING EXPERIENCE FOR SOP DEVELOPMENT AND MANAGEMENT
DETAIL ORIENTED, WITH ABILITY TO AFFECT CHANGE AND BUILD TEAM SPIRIT AROUND CONTINUOUS IMPROVEMENT EFFORTS