QA Specialist II/III - Molecular Characterization Lab (MoCha)

QA Specialist II/III - Molecular Characterization Lab (MoCha)

Job ID: req3322
Employee Type: exempt full-time
Division: Clinical Research Program
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION         

The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research’s Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research (FNLCR). The MoCha Laboratory is responsible for providing high-level research in support of the NCI-Cancer Diagnostics Program (CDP) within 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.  MoCha is comprised of several laboratory (research and clinical) units which include two CLIA accredited laboratories.

***This position can be hired at either the QA Specialist II or III level***

KEY ROLES/RESPONSIBILITIES

The QA Specialist II/III supports the Molecular Characterization Laboratory (MoCha) at the Frederick National Laboratory for Cancer Research (FNLCR) as part of the NCI’s Cancer Diagnostics Program (CDP) within the Division of Cancer Treatment and Diagnosis (DCTD). The QA Specialist II/III assists with the regulatory activities supporting clinical assay development, application in clinical trials, and release of test results. The QA Specialist II/III reports directly to the Quality Assurance Manager II.

This position does not serve a CLIA role as defined in 42CFR493 Subpart M. Duties and responsibilities include but are not limited to:

• Perform record review for all patient-testing related records.
• Generate and review documents (SOPs, forms, etc.) relevant to patient-testing activities and research activities intended for future use with patients or FDA submission.
• Periodically observe laboratory activities to ensure that performance and quality conform to corporate and regulatory standards.
• Implement, maintain and offer suggestions to improve upon existing quality management systems and activities supporting the clinical assay laboratory and designated clinical trial platforms as assigned.
• Participate in interdepartmental quality initiatives and processes.
• Evaluate and report on quality issues related to assay systems and processes.
• Guide investigations and resolve quality issues with appropriate corrective and preventive actions.
• Continuing knowledge of current CLIA, CAP, and relevant GxP regulations and requirements.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education).
• Foreign degrees must be evaluated for U.S. equivalency.
  • Specialist II, QA - In addition to the education requirement, a minimum of two (2) years of progressively responsible experience.
  • Specialist III, QA - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience.
• Demonstrated track record of QA/QC responsibilities.
• Knowledge of molecular characterization laboratory operations.
• Familiarity with Clinical Laboratory Improvement Act (CLIA) regulations and/or accrediting body standards, and as well as FDA Good Laboratory/Clinical/Manufacturing (GxP) regulations.
• Preferably, familiarity with FDA submissions, such as IND, IDE, etc.
• Ability to obtain and maintain a security clearance.

OTHER REQUIREMENTS:

• Technical: Working knowledge of Microsoft office applications such as Word, Excel, PowerPoint as well as any lab-specific applications utilized in patient testing activities.
• Communications:  Excellent writing and editing skills with clear and effective presentation skills; ability to work within a highly matrixed team environment.
• Security:  Subject to Public Trust Clearance.
• Functionality: Ability to work in Biosafety Level II laboratory conditions as well as standard office/administration conditions. Work may involve the use of potentially hazardous chemical or biological materials or may be located in areas where such materials are used, requiring the use of personal protective equipment and adherence to strict safety protocols.

 JOB HAZARDS

• 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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