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The Manager, Pre-Analytical Lab leads teams in specimen receiving, accessioning, and processing. This role also leads the Pre-Analytical team in monitoring the ingress and flow of clinical lab samples from receipt through ingress into the analytical side of the clinical lab. The manager is responsible for staffing and establishing systems for receiving and processing laboratory specimens according to CAP and CLIA regulations. This individual provides expertise and mentoring to pre-analytical supervisors and serves as the liaison to internal and external entities including Exact Sciences Corporate and external relationships. The Manager assists with the design, maintenance, and implementation of the Quality Management programs across the laboratory(ies) and ensures the laboratory and the staff are in compliance with all laws and regulations required by CLIA, CAP, OSHA, CMS and any other applicable legislative organizations (consults with the appropriate international partner as needed for overseas operations).
Job Responsibility:
Oversees the week to week, month to month operations of the preanalytical lab
Supports the leadership teams and removes bottlenecks in the daily workflow of the preanalytical departments
Participates in the hiring process for new team members
Supports leadership team in the identification of and follow up to employee performance issues, counseling, and corrective action
Aligns staffing to forecasted sample volumes
Maintains and supports employee morale and engagement initiatives
Identifies and understands regulatory requirements to ensure that the laboratory complies with all applicable state and federal laws and regulations pertinent to the management of the laboratory
Participates in cross-functional stakeholder meetings to ensure consistent processes for staffing, recruiting, training, evaluating competency and ongoing employee development
Works strategically with department leadership to ensure testing is completed within turnaround time expectations
Partners with senior leadership in establishing strategic priorities and annual quality indicators
Provides oversight to ensure prompt, accurate, and timely processing, and delivery of all patient specimens
Accomplishes financial objectives by assisting with forecasting requirements and preparation of budgets
Maintains quality service by enforcing quality and customer service standards, analyzing, and resolving quality and customer service problems, and recommending improvements
Accomplishes results by ensuring expectations are clearly communicated, understood, and performance is monitored, and appraised
Lead, manage and support projects for continuous improvement of systems and processes
Participates in cross-functional activities to assist with the design and implementation of new automation and new processes
Review, write, and update SOPs
Requirements:
Bachelor’s degree chemical, physical, biological, or clinical laboratory/medical technology science, or related field
or High School Degree/General Education Diploma and 4 years of relevant experience in lieu of Bachelor’s degree
5+ years of work experience in a laboratory or similar environment (e.g., maintaining sample integrity, following procedures and protocols, and/or sample collection/handling)
2+ years with extensive laboratory sample processing background
2+ years in a role with progressively increasing responsibilities such as supervisor or system function oversight
Familiarity with QMS
Strong understanding of regulatory requirements to ensure the laboratory is in compliance with all applicable laws and regulations pertinent to the management of the laboratory
including applicable CLIA, CAP, OSHA, CMS, and other related legislative and/or state health departments and organizations, such as California and New York (CLEP) laboratory programs
Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook
Authorization to work in the United States without sponsorship
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Nice to have:
Master of Business Administration, Master of Health Administration, or Master of Science
Lean/Six Sigma Certification
Experiencing managing large teams
What we offer:
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage