Quality Assurance Manager I/Ii : Mocha Clia Lab (Req1118)

Quality Assurance Manager I/Ii : Mocha Clia Lab (Req1118)
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Quality Assurance Manager I/Ii : Mocha Clia Lab (Req1118)

Details of the offer

Quality Assurance Manager I/II : MoCha CLIA Lab

Job ID: req1118
Facility: Frederick: Ft Detrick
Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases.

Position Overview:

PROGRAM DESCRIPTION

The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Researchs Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research. The MoCha Laboratory is responsible for providing high:level research and clinical laboratory support of the Division of Cancer Treatment and Diagnosis (DCTD). MoCha is charged with the development and application of genomic assays for use in medical research and diagnostics for DCTD:sponsored national extramural clinical trials.

This is a Dual Level Req for a Quality Assurance Manager I or Quality Assurance Manager II. Either level may be filled with this req.

KEY ROLES/RESPONSIBILITIES

This position is an integral part of a multi:disciplinary team effort leading the implementation of next:generation sequencing and other clinical assays (eg IHC and FLOW) in nation:wide clinical trials seeking to identify prospective treatments for cancer patients. This position will provide quality support to the National Clinical Laboratory (NCLN) and a Molecular and Immunologic Diagnostics Network of Laboratories (MDNet) networks, including implementation and management of harmonized procedures as well as Lead Quality Assurance oversight for the multiple network laboratories.

The Quality Assurance Manager I/II reports to the MoCha CLIA Director and will support the MoCha CLIA laboratory. Specific duties will include:
Development of Quality Program to manage the development and maintenance of harmonized procedures and documents for laboratory functions related to MDNet operations Developing and presenting quality:related training to the NCI National Clinical Laboratory Network (NCLN) and MDNet laboratory participants Oversight of harmonized quality efforts related to the MDNet laboratories Conduct of quality reviews/audits (study:specific, process:based, and/or facility:based) within the MoCha CLIA Laboratories for studies conducted under the MDNet Representing MoCha Quality Assurance during team meetings and during interactions with clients/subcontractors, including project network laboratories This position is located in Frederick, MD. Consistent Onsite presence will be required
BASIC QUALIFICATIONS
Possession of a Bachelors degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a biomedical or related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. QAM Level I: A minimum of six (6) years of relevant experience in quality assurance in US:regulated clinical studies QAM Level II: A minimum of eight (8) years of relevant experience in quality assurance in US:regulated clinical studies
Both levels must have:
Demonstrated knowledge and experience with CLIA and/or CAP regulations, specifically in a high:complexity certified clinical laboratory Demonstrated complex laboratory experience Knowledge of quality assurance concepts and practices, and in management and oversight of quality systems (eg, change control, deviation reporting, training, document control, review and inspections) Knowledge of quality control applications Experience with electronic document control (local or web:based) Extremely detail:oriented with strong organizational, analytical, and problem:solving skills with the ability to multi:task Ability to independently conduct audits and quality reviews Ability to communicate effectively, both verbally and in writing, with non:technical and technical staff at various levels of


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