Quality Assurance Manager I/II - MoCha CLIA Lab
Job ID: req1187
Employee Type: exempt full-time
Facility: Frederick: Ft Detrick
Location: PO Box B, Frederick, MD 21702 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.
The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research's 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.
This position is an integral part of a multi-disciplinary team effort leading the implementation of next-generation sequencing and other clinical assays (e.g. 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
- Possession of a Bachelor's 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 progressively responsible quality assurance experience in US-regulated clinical studies, including two (2) years of experience in a leadership capacity
- QAM Level II: A minimum of six (6) years of progressively responsible quality assurance experience in US-regulated clinical studies, including four (4) years of experience in a leadership capacity
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 (e.g., 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 the organization
- Ability to function independently and collaboratively within the team setting
Familiarity with interactive databases, auditing techniques, metrics development and analysis, risk assessment
- Ability to travel approximately 10%
- Must be able to obtain and maintain a security clearance
- Working knowledge of Word, Access, Excel, PowerPoint
- Working knowledge of local or web-based document systems, specifically MediaLab, SharePoint
- Knowledge of Food and Drug Administration (FDA) regulations and good practices (GxP), including Good Laboratory
- Knowledge Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and/or Good Manufacturing practices (GMP)
- Tangential experience in related disciplines, specifically molecular characterization and next-generation
JOB HAZARDS OR REQUIREMENTS
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
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