QC Analyst II (req2199)

Posted: 10/18/2021
Location: Frederick, MD
Employee Type: exempt full-time
Job ID: req2199

PROGRAM DESCRIPTION

The Vaccine, Immunity and Cancer Directorate mission is to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV), SARS-CoV-2 infection and vaccines as well as other cancer preventive strategies in the context of clinical and pre-clinical studies.

KEY ROLES/RESPONSIBILITIES

  • Conduct routine and non-routine analysis of samples, including Quality control samples, standards and reagents according to standard operating procedures (SOPs)
  • Conduct assay validation, including robotics testing
  • Participate in the development of QC samples and procedures
  • Ensure compliance with SOPs, and GCLP regulations
  • Follow good documentation practices to ensure appropriate documentation of test results
  • Perform required data analysis, review data, interpret data findings, investigate issues and report abnormalities, troubleshoots analytical methods
  • Prepare and submit data summaries for review
  • Responsible to perform routine maintenance and troubleshooting on lab equipment and procedures
  • Participate in out-of-specification investigations and recommend corrective actions
  • Draft and revise SOPs, data sheets and reports
  • Maintain the safety and orderliness of the lab
  • Adhere to a high standard of documentation practices to ensure appropriate documentation of quality control test results

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of two (2) years of job-related experience
  • Ability to follow SOPs and comply with GCLP
  • Experience working with immunology and molecular biological techniques including ELISA, Luminex and other multiple assays, viral neutralization assays, RT-PCR, plasmid and protein production
  • Ability to work with electronic database systems such as LIMS
  • Detail oriented with strong organizational and verbal communication skills
  • Ability to work well in a team environment
  • Knowledge of Bioanalytical laboratory equipment
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Experience using reference materials
  • Experience with immune assay (ELISA, multiplex assays) development and validation
  • Understanding of regulatory and GCLP/CLIA requirements
  • Experience with robotics and assay automation

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations