Manager, Specimen Processing
Summary of Major Responsibilities
The Manager of Specimen Processing manages the Specimen Processing department at Exact Sciences Laboratories. The position is responsible for overseeing the processes related to technology transfer of new assays, new sample types or assay improvements which may include the general supervision and development of all aspects of implementation. This may include but is not limited to space planning, coordination of cross-functional resources (ie. IT), and development of processes, procedures, and training of laboratory staff, assuring that quality standards are being met consistently and processes and systems are consistently emulated across all sites. This individual provides expertise and mentoring to laboratory staff and serves as the liaison to internal and external entities including Exact Sciences Corporate and vendor relationships. This position is also responsible for incorporating and being part of the oversight group for the sample management system. The Manager will assist 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).
Essential Duties and Responsibilities
- Participates in cross-functional activities with vendors (including Exact Sciences Corp) on technology needs or improvement suggestions
- Works with all the laboratory management teams as a senior mentor throughout all the implementation stages (scoping, planning, implementing and maintaining)
- Identify and understand regulatory requirements in order to make sure the laboratory is in compliance with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP and other requirements and regulations such as California and New York (CLEP) laboratory programs.
- Evaluate space, equipment and supply needs to implement the process in the laboratory. This includes:
- Works with the Director of Laboratory Operations to control expenses within the budget
- Ensure proper ordering of supplies and equipment
- Monitor supply usage and variances
- Maintains competency in the all areas of the technical processes in the laboratory
- Assists as needed with the supervision of the laboratory and is accessible to the laboratory personnel to provide on-site, telephone or electronic consultation.
- Ensure that the quality management program is maintained by following parameters for acceptable performance for the pre-analytical and post-analytical testing processes
- Resolve all non-technical problems with the aide of the applicable staff and ensures that remedial action is taken whenever a process deviates from the laboratory’s standards
- Ensure that all patient results are not reported until corrective actions have been taken and the systems are functioning properly
- Identify training needs and ensures all training is performed as required
- Evaluate competency of personnel
Mandatory Skills & Qualifications
- Proven experience in the areas of laboratory supervision, IT requirements and workflow needs and Technical capabilities listed under the Essential Functions section of this document.
- Possess effective management abilities so as to supervise department staff and maintain budgets.
- Experience working with Quality Management including strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA, CMS and other related legislative and/or state health departments and organizations.
- Ability to work cross-functionally across different operations within the organization.
- Excellent communication skills, both oral and written including the ability to speak in a public setting to a large audience.
Necessary Education & Experience
- Bachelor degree in the physical or biologic sciences.
- Minimum of eight years of experience in a clinical laboratory with extensive sample processing background in a high complexity testing clinical laboratory setting with four years on a role with progressively increasing responsibilities such as laboratory management, staff management, quality and control, lead technologist, or technical specialist.
Physical Requirements & Working Conditions
- Ability to lift and move 20-40 pounds on an occasional basis (up to 25% of time).
- Ability to stand, walk, bend and reach on a regular basis (standing ~25% of time; sitting ~75% of time).
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to listen and speak on the telephone and write simultaneously.
- Ability to operate telephone system and computer keyboard and printer.
Visual, hearing, dexterity and mental demands
- Vision: Adequate to perform the essential functions of the job such as read and perform lab tests.
- Hearing: Adequate to perform the essential functions of the job such as hear timers go off, etc.
- Speaking: Excellent communication skills to perform the essential functions of the job such as communicating with staff, patients, colleagues and providers.
- Dexterity: Adequate to perform the essential functions of the job along with computer work.
- Mental Demands - Adequate to perform the essential functions of the job such as the stress of laboratory work and performing multiple tasks simultaneously.
- Overseeing and dealing with the management pressures on a daily basis.
- Position requires work in normal laboratory environment. Special uniform and personal protective equipment is required while working in the laboratory.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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