Biological Scientist

Summary

This 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,

Duties

• Maintain 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.

Qualifications

Applicants 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.

Education

Please see above for education qualification requirement information.

How to apply

Please read the entire announcement and all instructions before you begin. You must complete this application process and submit all required documents electronically by 11:59p.m. Eastern Time (ET) on the closing date of this announcement. Applying online is highly encouraged. We are available to assist you during business hours (normally 8:00a.m. - 4:00p.m., Monday - Friday). If applying online poses a hardship, contact the Agency Contact listed below well before the closing date for an alternate method. All hardship application packages must be complete and submitted no later than noon ET on the closing date of the announcement to be entered into the system prior to its closing. Resumes must not exceed two pages. This agency provides reasonable accommodation to applicants with disabilities on a case-by-case basis; contact the Agency Contact to request this. To begin, click "Apply" and follow the instructions to complete the Assessment Questionnaire and attach your resume and all required documents. Please verify that documents you are uploading from USAJOBs transfer into the Agency's staffing system as there is a limitation to the number of documents that can be transferred. However, once in the Agency's staffing system, you will have the opportunity to upload additional documents. Uploaded documents must be less than 5MB and in one of the following document formats: GIF, JPG, JPEG, PNG, RTF, PDF, TXT or Word (DOC or DOCX). Do not upload Adobe Portfolio documents because they are not viewable. Please ensure your resume does not exceed two pages. Applicants who submit a resume that exceeds two pages will be removed from consideration.