QA Specialist Lot Release, Vaccine/Biologics (req2017)

Company: Frederick National Laboratory
Location: Frederick
Posted on: September 9, 2021

Job Description:

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 biologics to address current and/or emerging infectious diseases of global significance (e.g. HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

Reporting to the QA Lot Release Supervisor, the QA Specialist, Lot Release, will:

• Support QA management in the establishment and implementation of quality systems in accordance with cGMP
• Perform routine review of all documentation generated both internally and under contract in support of cGMP manufacturing including, but not limited to, QC test results, production batch records, component specifications, and environmental monitoring results to assure compliance with established quality systems and cGMP
• Perform QA on the floor activities to monitor GMP operations
• Perform routine release of material prior to manufacturing use
• Support the QA team review of investigations, validation packages and process development data reviews
• Participate in the generation and review of new and revised documents (e.g., SOPs, MBRs, test records, and other cGMP critical support documents)
• Participate in the generation of trending key indicators (deviations, investigations, environmental monitoring excursions, CAPAs)
• Participate in internal inspections and team meetings to facilitate the implementation of quality systems

• Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) 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 five (5) years of progressively responsible experience
• Four (4) 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 in performing routine internal audits
• Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources
• Ability to obtain and maintain a security clearance

• 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

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Keywords: Frederick National Laboratory, Frederick , QA Specialist Lot Release, Vaccine/Biologics (req2017), Other , Frederick, Maryland