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Senior Manager, Accessioning

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Manager, Accessioning is a leadership position in the Laboratory Operations organization responsible for managing the entirety of the Accessioning team including: strong technical workforce knowledge, skills and abilities, technical training, professional development, mentoring, educating and supporting the Accessioning staff, as well as monitoring the work of this team to ensure that all specimens are received, sorted, and entered in a compliant and timely manner into the Lab Information System, labelled, and processed in accordance with the regulations established by the Certified Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and New York state. This position drives production within the Accessioning department and is a key player in maintaining operational performance that ensures the consistent highest quality of FMI’s services. The incumbent in this position maintains coordination and people leadership of all accessioning functions and meets corporate goals for turn-around-time.

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines. 

Key Responsibilities

• Plan and supervise the daily operation of the Accessioning department within the production laboratory to ensure that schedules are maintained, and all deadlines are met.

• Develop strategy for all major accessioning workflows and provide information on this to Accessioning Managers/Supervisors and their staff for optimal process including but not limited to: receiving samples, counting, sorting specimens and tracking, entering patient information, test requests, and other pertinent information, scrutinizing all samples for the highest level of service and efficiency.

• Participate in strategic workforce planning, interviewing and hiring of Accessioning technicians.

• Deploy problem-solving skills to assess and identify areas for process improvement and to solve for complex business challenges.

• Ensure proper GDP, documentation, rectify and create a continuous improvement culture.

• Evaluate employees’ performance against error rate, productivity, and TAT metrics.

• Make recommendations regarding the hiring, performance management and development of laboratory technicians, including coach and mentor to high performance.

• Ensure the effective use of resources through monitoring of key metrics, data, and use of other applicable tools.

• Partner directly with the Quality Control department to ensure the highest quality standards are maintained.

• Partner directly with the Client Services department to ensure timely responses to patient or physician inquiries.

• Provide input and recommendations to improve daily operations in own department or in the laboratory as a whole.

• Coach and counsel Accessioning employees on remediation steps when standard operating procedures or corporate policies are violated.

• Ensure compliance is engrained in every step of the process and training is up to date for all operational procedures.

• Facilitate resolution to LIMS system malfunctions.

• Maintain proper documentation including proper specimen handling, labeling and preparation of worksheets.

• Participate in and promote quality assurance activities, accuracy and integrity of specimen processing.

• Ensure specimen identification and integrity is maintained throughout all processes.

• Enforce and educate regulatory compliance by following department and corporate safety policies.

• Participate in biohazard, chemical, and radiation safety and other continuing education programs and label and dispose of biohazard waste appropriately.

• Author, contribute to, and review standard operating procedures (SOPs), tracking forms, training logs, change controls, non-conformance reports and investigations, and deviations or CAPA reports, as needed to support operational excellence.

• Exercise judgment and decision-making authority in determining methods, techniques and evaluation criteria for obtaining business-critical results.

• Collaborate with other departments and colleagues.

• Perform other duties as assigned.

Qualifications

Basic Qualifications

• High School Diploma or General Education Degree or Equivalency

• 8+ years of relevant experience in a regulated environment, such as biotech, manufacturing, clinical laboratory pre-analytical sample processing, biobanking, biomedical material processing or equivalent handling patient samples in healthcare

• 5+ years of management experience with proven track record of implementing changes, scaling operations for growth, staff development and building successful teams

Preferred Qualifications

• 5+ years of experience in leading process or quality improvement projects

• Demonstrated experience with allocating resources and prioritizing key deliverables to optimize delivery timelines while meeting all critical requirements

• Knowledge of Document Control Systems

• Prior use of laboratory management systems or the ability to learn these systems

• Demonstrated meticulous attention to detail and strong organizational skills

• Ability to work in Laboratory environment

• Ability to lift up to 25 lbs when required

• Ability to work well under pressure while maintaining a professional demeanor

• Ability to handle multiple tasks at once and work in a fast-paced environment

• Ability to prioritize and thoroughly follow up on assigned tasks

• Ability to adapt to changing procedures, policies and work environment

• Ability to work in clean room environment

• Strong verbal and written communication skills

• Strong computer proficiency and data entry skills

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

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Internal applicants, please use your FMI email address.

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