QC Analyst II

Job ID: req3287
Employee Type: exempt full-time
Division: Biopharmaceutical Development Program
Facility: Frederick: ATRF
Location: 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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

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

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

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