QC Analyst II

QC Analyst II

Job ID: req2573
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 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
Within Leidos Biomedical Research Inc. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum. The quality assurance programs provide the required autonomy and transparency of Good Manufacturing Practice quality assurance operations. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations. These support services include dedicated clinical research professionals who provide patient care to clinical trial participants at the National Institutes of Health (NIH) Clinical Center, and other research services that support the domestic and international clinical research initiatives of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and several other institutes within NIH. CRD’s support services are strategically aligned with its mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, protecting human subjects, and helping to advance scientific clinical research. CRD facilitates the conduct of NIH-sponsored clinical trials that investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, parasitic infections, heart, lung and blood disorders, and rare and neglected diseases. CRD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CRD’s mission has contributed to improving the overall standards of public health on a global scale. 

The Clinical Research Directorate (CRD) provides analytical experience to work on innovative T-cell therapy for cancer treatment, and responsible for development and execution of analytical assays for generation lot release assays and product CoAs in support of the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB). 

KEY ROLES/RESPONSIBILITIES

• Performs Quality Control (QC) testing of materials, intermediates, and final products manufactured for first-in-human immunotherapy clinical trials
• Performs cell culture of human primary cells, ELISA, FACS, PCR and qPCR assays as required for lot release
• Identifies potential bottlenecks and works with team members and senior management to resolve them
• Performs required data analysis, compiles data, and prepares results for review
• Interprets test results, compares to established specifications and control limits and makes recommendations on appropriateness of data for release
• Provides updates at daily and weekly meetings
• Assists in developing testing and analysis methods and procedures in accordance with established guidelines
• Coordinates maintenance and calibration of equipment and instruments used in testing of clinical products
• Monitors the GMP systems currently in place to ensure compliance with documented policies
• Assists with investigations regarding out of specifications (OOS) results; addresses and manages deviations related to analytical procedures
• Works collaboratively to develop, revise, and review SOPs, qualification/validation protocols and reports
• Participates in internal assessments and audits
• Plans own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
• Trains new employees as required on techniques and SOPs
• Provides support with data documentation, technical writing, and document organization
• Performs daily maintenance and laboratory tasks
• This position is located in Bethesda, Maryland 

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 or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education)
• In addition to educational requirements, a minimum of two (2) years progressively responsible quality control experience
• Foreign degrees must be evaluated for U.S. equivalence
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
• Ability to follow SOPs and comply with cGMP regulations
• Develop analytical methods and generate SOPs
• Perform a variety of analyses including computer-based instrumental analytical methods
• Good technical writing skills
• Ability to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:  

• General knowledge of Biosafety Level 2 (BL2)
• Analytical equipment qualification
• Demonstrated ability to interface with Manufacturing, Quality Assurance, Materials Management 

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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