QC Microbiology Analyst (NCI)

Leidos FREDERICK, MD Closed
Leidos is looking for QC Microbiology Analyst (NCI) in FREDERICK, MD. This local job opportunity with ID 11118092 is live since 07/29/2018.
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 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 makes 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


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 five (5) years progressively responsible job-related experience in a cGMP environment
  • Working knowledge of current Good Manufacturing Practices (cGMPs) 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, bioburden and sterility testing.
  • 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

Candidates with these desired skills will be given preferential consideration:

  • Analytical equipment qualification
  • Use of electronic systems
  • Experience and knowledge of traditional and rapid Microbiology Methods
  • Experience with genotyping of microorganisms
  • Demonstrated ability to interface with Manufacturing, Quality Assurance and Materials Management

Expected Competencies:

  • Career-level (fully competent) experienced professional able to carry out a full range of professional duties, by working independently and receiving minimal guidance
  • Provides professional know-how to enhance the knowledge and skill base of the organization
  • Accountable for meeting own target which will impact the discipline
  • Impact is limited to the achievement of short- to medium-term goals
  • Contributes to delivery of discipline / department goals through personal effort or through influence over team members
  • In-depth knowledge of principles and practices within a professional discipline
  • Uses best practices and knowledge of internal or external business issues to improve products or services and suggests variations in approach
  • Devises solutions based on limited information and uses past experience, evaluation, and interpretation to identify solutions or to adapt existing approaches to resolve issues; which may impact the longer term
  • Solves complex problems; takes a new perspective using existing solutions
  • Requires strong multicultural awareness to appropriately deliver messages and adapts style to differing audiences
  • Acts as a resource for colleagues with less experience; may direct the work of other staff members


Employer Overview:
Employer 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, Employer 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 Employer with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Employer.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. Employer will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Employer is an equal opportunity employer/disability/vet. read more

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