Supervisor, Molecular Laboratory (Sun-Thurs, 3rd Shift)
Company: Disability Solutions
Location: Cambridge
Posted on: April 23, 2024
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Job Description:
About the Job
The Supervisor of the Molecular Laboratory manages a team of direct
reports and embodies thecompany's values in all aspects of managing
laboratory personnel. The Supervisor of the MolecularLaboratory is
a decision maker for questions and is a highly trusted team member
for all laboratorypersonnel. This role spends significant time
collaborating cross-site and cross-functionally to ensureefficient
workflow. The incumbent in this position may be assigned to work
any day that the lab isoperational and requires working in a lab
environment using chemicals and reagents. Titles are internalto
Foundation Medicine and may not align with Clinical
Regulations.
This is a regulated position and additional information may be
available from FMI Quality Assuranceregarding regulatory
guidelines.
Regular onsite work at a designated FMI location is an essential
function of this role.
Key Responsibilities
---Manage laboratory process to ensure day-to-day operations are in
compliance with internal standardoperating procedures and
regulatory standards of CLIA, FDA, and CAP.---Manage laboratory
personnel by preparing schedules for incoming shift to ensure
competent personnelare scheduled and prioritize work in progress to
meet turnaround time (TAT).---Demonstrate commitment to maintaining
TAT objectives, quality, and continuous improvement.---Perform lab
walkthroughs to review maintenance logs, lab cleanliness, waste
management and ensureadherence to PPE guidelines.---Establish 1:1
with direct reports and provide coaching and development.---Respond
to general inquiries such as sample, plate or process inquiries
from Client services and otherdepartments.---Be on the on-call
rotation for the molecular lab supervisors hotline to troubleshoot
any issue that come upon site.---Maintain flexibility to cover
scheduling gaps as needed and to be included in the on-call
rotation foradditional weekend and/or holiday technical
support.---Review Batch Records to ensure it is released to QA on
time.---Review Daily Management Board to ensure countermeasure are
set and reviewed for any issues thatmay have come up in the
lab.---Support all operational aspects of quality assurance and
quality control.---Hire and onboard new Technologists.---Contribute
to the maintenance or development of technical and analytical
standards for methodevaluation, development of quality improvement
initiatives, and evaluation of new instrumentation,analytical
methods and laboratory procedures.---Act as decision maker on
tactical issues operationally and systemically on designated
shift.---Provide training, competency evaluation, protocol
compliance management and annual proficiencybenchmarking of all
laboratory personnel.---Leverage a deep understanding of the
process in troubleshooting assays and instrumentation as
needed.---Investigate and problem solve laboratory and department
incidents, including driving the process forwardand reviewing
and/or writing non-conformance reports, deviations, CAPAs, and
incident reports asneeded in compliance with QMS
system.---Collaborate with internal teams, vendors, and others as
needed to resolve issues, maintain ongoingfunctionality and
document service, project management and repair work.---Participate
on cross-functional teams to coordinate troubleshooting and process
improvements, and/orimplement new workflows or products.---Assist
in preparing for, performing and responding to internal and
external audits as well as any otherinspections.---Represent the
laboratory operations department at cross-functional meetings or to
guests as needed.---Review and write standard operating procedures
as needed.---Continue building a cohesive team.---Other duties as
assigned.---Titles are internal to Foundation Medicine and may not
align with Clinical Regulations.
Qualifications:
Basic Qualifications---One of the three education or experience
combinations:--- (a) Bachelor's of Science Degree in a chemical,
physical or biological science and 7+ years ofexperience in a
molecular clinical laboratory (CLIA/CAP); OR,--- (b) Bachelor's of
Science Degree in Medical Technology and 6+ years of experience in
amolecular clinical laboratory (CLIA/CAP); OR,--- (c) Masters' of
Science Degree in Chemical, Physical or Biological Science and 4+
years ofexperience in a molecular clinical laboratory (CLIA/CAP),
at least 2 of which have been spentworking under the direction of a
doctoral level supervisor---Certifications or licensure that is
required by the state or country in which the job is posted---2+
years of leadership experience
Preferred Qualifications---Strong experience working in QSR
compliant lab or other regulated laboratory environment---Knowledge
and experience working with DNA manipulation techniques, enzymatic
reactions, andsequencing chemistry---Experience with ensuring and
maintaining integrity and quality of a lab in compliance with
QMS---Experience with a Laboratory Information Management System
(LIMS)---Demonstrated history working as a leader within a
team---Knowledge of accreditation and regulatory
standards---Knowledge of laboratory safety protocols---Familiarity
with high through-put platforms and common molecular laboratory
equipment (pipettes,thermocyclers, liquid handlers,
etc.)---Proficiency utilizing Microsoft Office Suite, specifically
Excel and Power Point---Strong interpersonal skills that include
excellent skills in written communication, oral
communication,collaboration, and problem solving with other
departments and colleagues---Excellent organization and attention
to detail---Understanding of HIPAA and importance of privacy of
patient data---Commitment to FMI values: patients, innovation,
collaboration, and passion.
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Keywords: Disability Solutions, Chelsea , Supervisor, Molecular Laboratory (Sun-Thurs, 3rd Shift), Hospitality & Tourism , Cambridge, Massachusetts
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