QC Microbiology Analyst - Weekend Rotation Included

Job ID: req2526
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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 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 biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

Reporting to the QC Microbiology Supervisor, the QC Microbiology Analyst:

• The schedule for this QC Analyst II will include weekends with flexibility in desired work week (example, 4 days 10-hours each Sat-Tues, or 5 days flexible hours Sat-Wed)
• May be required to work 2nd or 3rd shift or early mornings as needed to support manufacturing activities
• Performs routine testing of environmental samples, microbial analysis of water and compressed gasses, and microbial analysis of product samples
• Performs required data analysis, compile data and prepare results for review
• Conducts enumeration of viable air samples, microbial identification, bioburden analysis, and media qualification
• 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
• Interprets test results, compare to established specifications and control limits
• Performs microscopic techniques/cell counting, utility sampling, environmental monitoring
• Performs wet chemistry testing
• Will be responsible for data documentation and technical writing
• Will be responsible for daily laboratory maintenance tasks
• Prepares documentation for inspection/testing procedures
• Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records
• May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma)

THIS POSITION MAY ALLOW FOR FLEXIBILITY FOR SOME TELEWORK.

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 (CHEA) in biology, microbiology, chemistry, or similar scientific discipline (Qualifying four (4) years equivalent, directly relevant, experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of two (2) years of progressively responsible job-related experience
• Experience with environmental monitoring
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
• Ability to generate and follow standard operating procedure (SOPs), and comply with cGMP regulations
• Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis
• Experience and ability to execute microbiology assay methodologies including enumeration, gram staining, microbial identification, microbial limits and the ability to subculture. Good technical writing skills
• Exp erience working in a pharmaceutical testing environment
• 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
• Use of electronic systems E.g., MODA, LIMS
• Experience with utility sampling/testing
• Experience with gram staining
• Experience and knowledge of traditional and rapid microbial methods
• Experience with microbial identification using a genetic analyzer
• Experience generating EM trend reports
• Ability to develop analytical methods
• Experience in and ability to execute bioburden testing, sterility testing and media qualification
• Experience in chromatographic testing and spectroscopic testing

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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