QC Microbiology Analyst (NCI) Job in Maryland (MD), Research and Development Career, Full Time Jobs in Leidos Biomedical Research, Inc.
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QC Microbiology Analyst (NCI) job in Frederick Md

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Leidos Biomedical Research, Inc. jobs
Maryland (MD), Frederick Md
Job Code:  662448
Employer:  Leidos Biomedical Research, Inc.
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  Maryland (MD)
City:  Frederick Md
10/14/2018

Description
Description

PROGRAM DESCRIPTION

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

KEYROLES/RESPONSIBILITIES

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

  • Perform microbial analysis of water andcompressed air/gasses, and microbial analysis of product samples
  • Perform Environmental Monitoring
  • Perform required data analysis, compile dataand prepare results for review
  • Perform bioburden analysis and mediaqualification
  • Participate in internal assessments and audits
  • Plan own activities on a weekly basis inaccordance with established schedules and in accordance with group objectivesand priorities
  • Interpret test results, compare to establishedspecifications and control limits and makes recommendations on appropriatenessof data for release
  • Perform microscopic techniques/cell counting
  • Be responsible for data documentation andtechnical writing
  • Maintain the safety and orderliness of the lab
  • Generate trend reports
  • May be required to work 2nd or 3rd shift asneeded to support manufacturing activities


Qualifications

BASIC QUALIFICATIONS

  • Possession of a Bachelor's degree from anaccredited college or university according to the Council for Higher EducationAccreditation. (Additional qualifying experience may be substituted for therequired education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to the education requirement, aminimum of 2 years' job-related experience
  • Working knowledge of current Good ManufacturingPractices (cGMPs) and scientific principles
  • Ability to follow SOPs and comply with cGMPregulations
  • Develop analytical methods and generate SOPs
  • Perform a variety of analyses includingcomputer-based instrumental analytical methods
  • Working knowledge of a laboratory environmentand equipment used for pharmaceutical analysis
  • Experience working in a pharmaceutical testingenvironment
  • Experience and ability to execute microbiologyassay methodologies including enumeration, gram staining, microbialidentification, bioburden and sterility testing
  • Strong technical writing skills
  • Cleanroom and BL2 experience
  • Ability to lift up to 35 pounds and work in aBL2 environment
  • Must be able to obtain and maintain a securityclearance


PREFERREDQUALIFICATIONS

  • Analytical equipment qualification
  • Use of electronic systems such as MODA
  • Experience generating EM trend reports
  • Demonstrated ability to interface withManufacturing, Quality Assurance and Materials Management


Expected Competencies:

  • Intermediate professional role, responsible fordelivery of professional activities while receiving a moderate level ofguidance and direction
  • Focuses on providing standard professionaladvice and creating initial reports/analyses for review by experienced teamprofessionals
  • Accountable for meeting own targets whichimpact the immediate work area
  • Impact is generally limited to short-term teamperformance, occasionally on medium-term goals
  • Beginning to have more of a contributory impacton team performance
  • Requires knowledge and experience in owndiscipline and company policies, practices and procedures; still acquiringhigher level knowledge and skills
  • Determines a course of action based onguidelines and modifies processes and methods as required
  • Uses previous experience, analysis andinvestigation, to identify the most appropriate option to solve a range ofdiffering, but straightforward problems
  • Understands and communicates complexinformation within the specialization or recognized body of formal knowledge
  • In some instances, will need to conveyinformation to audiences not knowledgeable of the subject matter


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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.
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