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QA Specialist III - Quality Systems

Job ID: req1457
Employee Type: exempt full-time
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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 Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide.

KEY ROLES/RESPONSIBILITIES

Reporting to the Supervisor, QA Continual Improvement, the QA Specialist will:

  • Assist QA Management with Assay Validation Reviews, Change Controls, and Biennial Reviews
  • Facilitate and review records associated with Non-conformances and associated investigations
  • Support the Quality Risk Management program, facilitate risk assessments and review associated documentation
  • Analyze and report quality metrics
  • Participate in Material Review Board meetings, as requested by the QA Supervisor
  • Assist with writing and implementing controlled documents (i.e., SOPs, Policies, Protocols) which may entail significant system changes)
  • Train and mentor junior staff on interdepartmental processes
  • Train and mentor VCMP staff in activities critical to the success of the compliance department
  • Provide reports on a routine basis to QA management
  • Assist QA Supervisor with compliance related tasks
  • Assist QA Team with non-conformances, corrective actions, preventive actions, internal audits, and supplier management
  • Support QA management in the establishment and implementation of quality systems in accordance with cGMP

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 or 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 education requirement, a minimum 5 years related QA experience in a cGMP environment related to vaccine and biologics
  • Experience with quality systems compliant with FDA regulations for cGMP
  • Experience in the review of process batch and test records, deviations, CAPAs and change controls
  • Experience with Quality Risk Management programs
  • Experience in performing routine internal audits
  • Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources
  • Must be able to obtain and maintain a clearance

PREFERRED QUALIFICATIONS

  • Combination of QA and QC or manufacturing experience
  • Working knowledge of quality systems and TrackWise
  • Experience with the GMP manufacture of Phase I/II clinical material

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

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