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QC Microbiology Analyst III

Company: Frederick National Laboratory for Cancer Research
Location: Frederick
Posted on: December 22, 2019

Job Description:

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide. KEY ROLES/RESPONSIBILITIES Reporting to the QC Microbiology Associate Director, the QC Microbiology Analyst will: Perform microbial analysis of water and compressed gasses, and microbial analysis of product samples Perform required data analysis, compile data and prepare results for review Perform, microbial identification, bioburden analysis, and sterility testing Participate in internal assessments and audits Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities Interpret test results, compare to established specifications and control limits and make recommendations on appropriateness of data for release Perform microscopic techniques/cell counting Be responsible for data documentation and technical writing Maintain the safety and orderliness of the lab Generate trend reports May be required to work 2nd or 3rd shift as needed to support manufacturing activities BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Qualifying experience (4 years) in biology, microbiology, biochemistry or in a closely related science may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to education requirements, a minimum of five (5) years progressively responsible job-related experience in a cGMP environment Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles Ability to follow SOPs and comply with cGMP regulations Ability to develop analytical methods and to generate SOPs Experience performing a variety of analyses including computer-based instrumental analytical methods Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis Experience working in a pharmaceutical testing environment Experience and ability to execute microbiology assay methodologies including microbial identification, bioburden and sterility testing Experience in utility sampling/testing and environmental growth promotion testing Experience using electronic systems Experience generating trend reports Strong technical writing skills Cleanroom and BL2 experience Ability to lift up to 35 pounds and work in a BL2 environment Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience with analytical equipment qualification Experience and knowledge of rapid Microbiology Methods Experience with genotyping of microorganisms Demonstrated ability to interface with Manufacturing, Quality Assurance and 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)

Keywords: Frederick National Laboratory for Cancer Research, Frederick , QC Microbiology Analyst III, Other , Frederick, Maryland

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