QC Analyst II/QC Microbiology Analyst

Location
Frederick, MD, USA
Posted
Nov 22, 2018
Ref
JR96-70090
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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 air/gasses, and microbial analysis of product samples
  • Perform Environmental Monitoring
  • Perform required data analysis, compile data and prepare results for review
  • Perform bioburden analysis and media qualification
  • 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


BASIC QUALIFICATIONS
  • 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 addition to the education requirement, a minimum of 2 years' job-related experience
  • Experience performing environmental monitoring and utilities testing
  • 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
  • Analytical equipment qualification
  • Use of electronic systems such as MODA
  • Experience generating EM trend reports
  • Demonstrated ability to interface with Manufacturing, Quality Assurance and 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 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

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)