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QA Specialist III

Job ID: req1459
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 Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

  • Reviews batch records and test results for completeness, accuracy and conformance to specifications 
  • Reviews and releases raw materials for conformance to specifications
  • Performs in-process audits of manufacturing, analytical, and other activities
  • Performs area clearance activities
  • Assists with Quality Management System process audits
  • Assists in Supplier Evaluation including auditing of CMOs, testing facilities, and other support functions
  • Assists in the identification, documentation, investigation and follow up of quality events (deviations, corrective and preventive actions, etc.)
  • Assists with audits from regulatory bodies and external customers
  • Contributes to process improvement projects
  • Writes, and assists others in writing SOPs and other documents
  • Prepares supporting documentation for release of products
  • Ensures compliance with all applicable regulations (e.g. 21CFR210, 211, 600, 1271 and FDA/ICH guidelines)
  • Supports management in the collectionand trending of Key Performance Indicators (KPIs) and trending
  • Participates in team and project meetings

 BASIC QUALIFICATIONS

  • Bachelor’s degree for an accredited college or university.Foreign degrees must be evaluated for U.S equivalency
  • A minimum of 5 years quality assurance experience in a GMP regulated environment (21CFR211, 21CFR606, and related)
  • Ability to work in a team environment with minimal supervision to complete responsibilities
  • Must be able to communicate ideas clearly and effectively with all levels

PREFERRED QUALIFICATIONS

  • Experience in a Phase I/II clinical trial, GMP environment with biopharmaceuticals, viral vector manufacturing and/or cell therapy products
  • Experience with Quality System Management
  • Education or experience in a STEM environment

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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