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QC Microbiology Analyst (NCI)

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Job Number:
652255
Job Category:
Process Improvement / Quality Assurance
Location:
FREDERICK, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:
PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.


KEY ROLES/RESPONSIBILITIES

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

  • Perform routine testing of environmental samples, microbial analysis of water and compressed gasses, and microbial analysis of product samples
  • Perform required data analysis, compile data and prepare results for review
  • Conduct environmental enumeration of viable air samples, 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 makes recommendations on appropriateness of data for release
  • Perform microscopic techniques/cell counting, utility sampling, environmental monitoring
  • Perform wet chemistry testing, chromatographic testing, spectroscopic testing
  • Use immunochemical methods
  • Be responsible for data documentation and technical writing
  • Be responsible for daily maintenance laboratory tasks
  • PROGRAM DESCRIPTION

    The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.


    KEY ROLES/RESPONSIBILITIES

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

    • Perform routine testing of environmental samples, microbial analysis of water and compressed gasses, and microbial analysis of product samples
    • Perform required data analysis, compile data and prepare results for review
    • Conduct environmental enumeration of viable air samples, 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 makes recommendations on appropriateness of data for release
    • Perform microscopic techniques/cell counting, utility sampling, environmental monitoring
    • Perform wet chemistry testing, chromatographic testing, spectroscopic testing
    • Use immunochemical methods
    • Be responsible for data documentation and technical writing
    • Be responsible for daily maintenance laboratory tasks
    • This QC Analyst II will work Wednesdays through Saturdays, from 8:00 a.m. to 5:00 p.m.
    • May be required to work 2nd or 3rd shift or early mornings as needed to support manufacturing activities
    • May be required to work 2nd or 3rd shift or early mornings as needed to support manufacturing activities


Qualifications:
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). Foreign degrees must be evaluated for U.S. equivalency.
  • In additional to education requirements, a minimum of 2 years progressively responsible job-related experience
  • 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
  • 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 enumeration, gram staining, microbial identification, microbial limits and the ability to subculture
  • Good technical writing skills
  • Must be able to obtain and maintain a 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
  • Experience and knowledge of traditional and Rapid Microbial ID Methods
  • Experience with genotyping of microorganisms
  • Demonstrated ability to interface with Manufacturing, Quality Assurance, Materials Management

EXPECTED COMPETENCIES

  • Intermediate professional role, responsible for delivery of professional activities while receiving a moderate level of guidance and direction
  • Focuses on providing standard professional advice and creating initial reports/analyses for review by experienced team professionals
  • Accountable for meeting own targets which impact the immediate work area
  • Impact is generally limited to short-term team performance, occasionally on medium-term goals
  • Beginning to have more of a contributory impact on team performance
  • Requires knowledge and experience in own discipline and company policies, practices and procedures; still acquiring higher level knowledge and skills
  • Determines a course of action based on guidelines and modifies processes and methods as required
  • Uses previous experience, analysis and investigation, to identify the most appropriate option to solve a range of differing, but straightforward problems
  • Understands and communicates fairly complex information within the specialization or recognized body of formal knowledge
  • In some instances, will need to convey information to audiences not knowledgeable of the subject matter


Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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