QA Lot Release Specialist, Vaccine/Biologics

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 Supervisor, QA Lot Release, the QA Lot Release Specialist:

• Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production
• Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
• Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them
• Facilitates internal training on quality assurance requirements, processes, and procedures
• May perform audits and risk assessments
• Supports QA management in the establishment and implementation of quality systems in accordance with cGMP
• Performs 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
• Performs QA on the floor activities to monitor GMP operations
• Performs routine release of material prior to manufacturing use
• Supports the QA team review of investigations, validation packages and process development data reviews
• Participates 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

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 scientific related field or related field (Qualifying experience (4 years) in a scientific related field or related field may be substituted for the required education). 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 in the field of Quality Assurance in a cGMP environment
• 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

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

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