About this role
Job SummaryThis position is in the Quality and Select Agent Program Management Unit. Their mission is to ensure the highest standards of NBAF operations, regulatory Biologics Development Module compliance, and ARS scientific integrity. The incumbent coordinates with the Quality Assurance Manager and the Biologics Development Module Director to develop and implement a quality assurance management system consisting of specific policies/processes/procedures involving the technological transfer of vaccines,
QualificationsApplicants must meet all qualifications and eligibility requirements by the closing date of the announcement including specialized experience and/or education, as defined below. Basic Requirements for Biologics Series, 0401: Degree: Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. Related degree may include genetics. OR A combination of education and experience: Specifically, you must have courses equivalent to a major, as shown above, plus appropriate experience or additional education. AND In addition to meeting the basic education requirements described above, applicants must also meet additional qualification requirements as stated below: FOR THE GS-11: Applicants must demonstrate at least one full year of specialized experience equivalent to at least the GS-09 grade level in the Federal service. The specialized experience requirements for the GS-11 is fulfilled by having experience implementing and maintaining a laboratory Quality Management System (QMS) for biologics or comparable regulated products; performing quality audits; applying International Organization for Standardization standards (ISO)/Good Manufacturing Practice/Good Laboratory Practices (GMP/GLP) and biosafety standards; and authoring/revising SOPs and quality documentation in a high-containment or regulated laboratory setting. OR Education: You must have a Ph.D. or equivalent doctoral degree in biology, genetics, computational biology, bioinformatics, statistics, or a directly related field. Related degree may include chemistry. OR A combination of doctorate-level education and specialized experience as described above. FOR THE GS-12: Applicants must demonstrate at least one full year of specialized experience equivalent to at least the GS-11 grade level in the Federal service. The specialized experience requirements for the GS-12 is fulfilled by having experience leading implementation and continuous improvement of a laboratory Quality Management System (QMS) for biologics or comparable regulated products; conducting quality audits; applying ISO/GLP/GMP and biosafety standards; authoring/controlling SOPs and quality documentation; and using quality metrics and risk assessments to drive Corrective and Preventive Actions (CAPAs) in a high-containment or regulated laboratory environment. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Major DutiesMaintain current knowledge of International Organization for Standardization standards, World Organization for Animal Health and Good Manufacturing Practice/Good Laboratory Practices regulations and integrate these requirements into SOPs/practices.Maintain current knowledge of American Association of Veterinary Laboratory Diagnosticians (AAVLD) CVB policies and integrate these requirements into Standard Operating Procedures (SOPs) and practices.Plan, administer, and evaluate quality compliance program; initiate audits/inspections; and coordinate corrective actions to mitigate identified risks.Develop, document, and manage a Quality Management System (QMS), aligning with quality programs and all applicable laws and regulations.Monitor QMS effectiveness using QMS software, observations, and periodic reviews; contribute to internal Quality Assurance (QA) audits and management review reports.Develop, prepare, review, and interpret quality policies, SOPs, and program documents; guide authors/reviewers to meet QMS and facility documentation standards.Gather, calculate, and collate quality performance metrics; prepare reports that evaluate functionality, efficiency, and accountability.