Biopharma Accessioning Lead, (Tues-Sat, 1st shift) at Foundation Medicine, Inc. in Cambridge, Massachusetts

Job Description:

About the Job

The Accessioning Lead performs critical sample receipt and data entry functions in FMI's Certified Laboratory Improvement Amendments (CLIA)-certified clinical laboratory. This role helps to drive production within the accessioning department and assists in maintaining the daily operations within the production laboratory, ensuring schedules are maintained and deadlines are met. The Accessioning Lead is assigned to one of three shifts and may be assigned to work any day that the lab is operational.

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

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

• Perform data entry into the FMI Laboratory Information Management System, including assigning specific computer-generated identification numbers to each sample.

• Route samples into the appropriate workflow and ensure downstream staff is alerted to sample availability.

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

• Maintain specimen identification and integrity throughout all processes of the department.

• Dispose and label biohazard waste appropriately.

• Perform a Quality Control check of all assigned cases.

• Document Accessioning Non-Conformances, including the initiation and investigation of an escalated incident.

• Support in collecting and maintaining the Accessioning daily, weekly and monthly metrics.

• Perform weekly communication huddles with the Accessioning Team providing updates and feedback when necessary.

• Follow-up with Client Services regarding the resolution of complaints and providing feedback to the Accessioning team.

• Oversee the management of standard operating procedures (SOPs), both new SOPs plus updates and upgrades to existing standard operating procedures.

• Interview and participate in hiring of Accessioning Technicians.

• Ensure regulatory compliance by following local, business unit and corporate safety policies.

• Guide and mentor less experienced Accessioning Technicians in laboratory operations and procedures, providing best practice information to the team.

• Identify and inform supervisor of any issues that need to be escalated.

• Assist with accessioning schedule changes if requested by a supervisor, including occasional weekend or off-hours work availability.

• Create and assign the weekly task schedule for the department.

• Participate in biohazard, chemical, and general safety and other education programs.

• Represent Accessioning department in meetings and project groups.

• Other duties as assigned.

Qualifications

Basic Qualifications

• High School Diploma or General Education Degree AND 7+ years of experience working as an Accessioning Technician in an Accessioning department in a laboratory or other clinical diagnostics setting

• OR Bachelor's Degree AND 4+ years of experience working as an Accessioning Technician in an Accessioning department in a laboratory or other clinical diagnostics setting

Preferred Qualifications

• Bachelor's degree

• 4+ years of experience working in an Accessioning department in CLIA laboratory

• 8+ years of professional experience with accessioning and/or anatomic pathology

• Prior use of laboratory information management systems (LIMS)

• Knowledge of medical terminology, specifically anatomic pathology specimen descriptions

• Excellent computer/data entry and communication skills

• Demonstrated attention to detail and strong organizational skills

• Demonstrated experience handling multiple tasks at once

• Ability to work independently as well as collaborate with peers in a fast-paced and cross-functional results-oriented team environment

• Demonstrated experience working within tight timelines for successful execution of project and program goals

• Excellent verbal and written communication skills

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

• Ability to prioritize and thoroughly follow up on assigned tasks

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

• Understanding of HIPAA and importance of privacy of patient data

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