As a Biologics Compliance Assistant at the Center for Veterinary Biologics (CVB), you will be responsible for the initial analysis of documents submitted to Inspection and Compliance for the purposes of market release of product, results from inspection findings and responses to compliance issues. Your accuracy affects the decision-making regarding marketing authorization of individual lots of product, inspection findings and regulatory actions, and has both national and international impact.

Duties

The duties may include, but are not limited to: Receives complex compliance reports and reviews for completeness and presence of supporting documentation. Completes initial examination of each Veterinary Biologics Production and Test Reports received from biologics manufacturers (used to assess the marketability of each veterinary biologics lot). Racks and processes individual actions, recognizing discrepancies and resolving conflicts and problems using own judgment or referring controversial matters to team lead or supervisor. Performs review of commercial firm blueprints, firm personnel forms, and stakeholder requests according to the 9 CFR, firm Outlines of Production, and Veterinary Biologics Memoranda. Reviews incoming correspondence relating to biologics program matters to determine whether a reply should be made on own initiative or submitted to Specialists for handling. Develops and maintains standard operating procedures and work instructions, hard copy and electronic, regarding procedures used for technical review and processes for IC incoming/outgoing documents. Composes and/or prepares correspondence, memoranda, reports, forms, and other material to CVB officials, biologics manufacturers, and others in connection with biologics operations.

Requirements

• You must be a US Citizen or US National.
• Individuals who were born male after 12/31/1959 must be Selective Service registered or exempt.
• Subject to satisfactory adjudication of background investigation and/or fingerprint check.
• Successful completion of one-year probationary period, unless previously served.
• Direct Deposit: Per Public Law 104-134 all Federal employees are required to have federal payments made by direct deposit to their financial institution.
• Successfully pass the E-Verify employment verification check. To learn more about E-Verify, including your rights and responsibilities, visit E-Verify at https://www.e-verify.gov/
• Work is performed in an office setting and involves some standing, bending, and walking, but no unusual physical exertion is required.

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. FOR THE GS-07 LEVEL: Applicants must have one year of specialized experience (equivalent to the GS-06 level) that may have been obtained in the private or public (local, county, state, Federal) sectors which demonstrates: Applying regulations, policies and procedures that are administrative in nature against customer/client document submissions. Adhering to and applying policies and procedures set forth in a Quality Management system to ensure documents are routed, reviewed and finalized to meet regulatory rigor. Providing customer service in a regulated environment which requires documenting the service and interactions such as in a tracking system, records management system, or notations in file. Note: There is no education substitution for this grade level. 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

This position does not have an education qualification requirement.

Contacts

• Address Animal and Plant Health Inspection Service USDA APHIS MRPBS 250 Marquette Avenue, Suite 410 Minneapolis, MN 55401 US
• Name: MRP Human Resources
• Phone: 612-336-3227
• Email: [email protected]