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QC Analyst II

Job ID: req1564
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION

The Clinical Services Program's primary mission is to perform sequential studies using samples obtained from patients with cancer, AIDS, chronic granulomatous disease or other diseases associated with immunologic dysfunction, as well as to monitor viral load in patients with HIV.

The Vaccine, Immunity and Cancer Program investigates immune responses to vaccines in preclinical and clinical studies, with a focus on HPV and more recently on COVID-19 serology.

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

  • Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field 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 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
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

  • 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

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

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