Laboratory Manager Covid-19

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**MEMBERS ONLY**SIGN UP NOW***. has established an internal laboratory facility with a workflow that offers PCR-based SARS-CoV-2 assessments for the university community as well as several universities in the Commonwealth of Virginia and West Virginia.
The Clinical Laboratory Manager will be hired to manage the COVID laboratory’s procedure for specimen collection, handling, and processing, as well as test analyses, reporting, and maintaining records of test results. Follow the laboratory’s quality control policies.
Coordinate instrument maintenance and procedural calibrations as well as document all quality control activities, instrument or procedural calibrations, and maintenance. In addition, it is anticipated that the Clinical Laboratory Manager will be responsible for completing monthly lab staffing schedules and ensuring that working conditions are compliant with safety policies as defined by OSHA, CDC, and the Virginia Department of Health.
The laboratory manager will have a thorough understanding of all workflow components to enable the identification and resolution of any issues that may arise during daily operations. These components include coordination with sample collection locations, sample accessioning, and tracking in the LIMS/LIS system, sample processing on manual and automated platforms, assay execution, data analysis, and reporting.
The COVID
Laboratory Manager will supervise and coordinate the activities of a team of four to eight laboratory technicians and be responsible for staff adherence to operational and safety SOPs and for QC checks before data reporting. This role reports to the CLIA Laboratory Operations Leader.
Duties and Responsibilities
Oversee a group of laboratory-based technicians, which perform testing by following established standard operating procedures for specimen handling and processing, test analysis, and reporting of results.
Perform ongoing quality monitoring, ensuring that all group members adhere to quality control policies.
Identify problems that may adversely affect test performance and
implement
appropriate corrective action.
Run monthly internal QA proficiency testing and reporting.
Oversee assay validation projects and implement process improvements or new tests.
Oversee training and personnel competency activities.
Provide daily operational summaries for management.
Interact with Facilities staff, Health and Safety staff, and other logistics groups as needed.
Ensure that stock of all reagents and consumables
is
at optimum levels.
Requirements
Schedule:
Monday to Friday.
Experience:
Relevant 5 years high complexity testing.
PCR testing
Education:
Bachelor (Required)
License:
ASCP (Preferred)
Work Remotely:
No
Qualifications
Bachelor of Science degree in medical technology, chemistry, biology, or related life science, and 5 years high complexity testing work experience or Master of Science degree in a related field, plus 5 high
complexity testing work
years’ experience
; or Ph.D. plus 5 high complexity testing work
years
’ experience
MLS (ASCP)
Familiarity with automated liquid handling platforms, qPCR, and LIMS/LIS operations is required.
Familiarity with CLIA standards and experience with laboratory regulatory inspections.
Experience
in
bench testing and performance management.
Work in BSL2 laboratory with previous experience with automation and molecular biology techniques required.
Experience working in a Biological Safety Cabinet
is
required.
Experience working in a CLIA environment
is
preferred.
Clinical diagnostics background preferred (molecular tests).
Work with human biological specimens.
HepB
Vaccination
is
advised.
Work with samples, which may contain SARS-CoV-2.
Attention to detail to ensure chain of custody of all samples.
Working and communicating across a fast-paced cross-organizational team.
Ability to rigorously follow SOPs.
Alternative pattern shift work.
Ability to follow CAPA (Corrective and Preventive Action) procedures.
Ability to work with on and
off-site
service providers.
Ability to prepare documentation of daily lab throughput to present
on
at daily
Working conditions include possible daily commute,
and
wearing PPE constantly
including
disposable
masks
, face
shields
, and latex gloves.

Company info

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