Job Details - QC Analyst - 45814549 | Frederick National Laboratory Talent Network
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QC Analyst II in United States of America

Location: United States of America
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

PROGRAM DESCRIPTION         

The Biopharmaceutical Development Program (BDP) supports the Frederick National Laboratory for Cancer Research (FNLCR) through the development of novel agents for first-in-human clinical studies. 

KEY ROLES/RESPONSIBILITIES

  • cGMP Quality Control analyst for biopharmaceutical testing
  • Analytical support for the NCI CAR-T cell therapy program
  • Sample testing, data analysis and writing technical reports
  • Develop, revise, and review SOPs, protocols, and technical reports
  • Support of QC functions (SOPs, logbooks, deviations, audits, investigations, CAPA, training, change control, and technical reports)
  • Performing instrument and assay validation or qualification procedures

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/university according to the Council for Higher Education Accreditation (CHEA) in a related field. Additional qualifying experience may be substituted for the required education
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the educational requirements, a minimum of two (2) years experience
  • Biotechnology field knowledge in analytical testing
  • Ability to implement a rigorous testing program with appropriate operating procedures and cGMP compliance
  • Experience in data evaluation, trending and troubleshooting
  • Excellent technical writing skills
  • Proficiency with analytical methods including flow cytometry, PCR and spectrophotometry
  • Prior experience with instrument and process validation or qualification procedures
  • Knowledge of GMPs, SOPs, good documentation practices and quality control operations
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Knowledge of the USP, ICH and FDA guidelines related to product testing
  • Experience with DNA, immunological and cell-based technology platforms
  • Proficiency with Microsoft Office, data analysis software, and other lab related applications
  • Strong written and verbal communication skills.
  • Experience with method development, qualification/validation

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • This position may require continuous or intermittent exposure to and exertion in environmental conditions such as working outdoors, temperature extremes, humidity extremes. etc. as part of the job


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