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Job opening: Lead Biologics Compliance Assistant

Salary: $51 993 - 67 595 per year
City: Ames
Published at: Nov 07 2023
Employment Type: Full-time
The Lead Biologics Compliance Assistant for Inspection and Compliance (IC) is responsible for management of the day to day workload regarding 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 and general support for IC program personnel. Your work will help to ensure harmful veterinary biologics and diagnostics are not shipped or marketed in the United States.

Duties

The duties may include, but are not limited to: Distribute, coordinate and prioritize the workload among employees, assure timely accomplishment of the assigned workload, and assure adequate distribution of workload for each employee. Provide leadership for other Biologic Compliance Assistants (BCAs) regarding all technical aspects and make day- to- day adjustments in accordance with established priorities. Instruct employees in specific tasks and job techniques and make available written instructions, reference materials and supplies. Trains BCA's in biologics program review, workload prioritization, file system, computer entry, updating files, and form processing. Collects data using program records, reports and relevant background information for the purpose of special projects assigned, recurring reports. Completes initial examination of each Veterinary Biologics Production and Test Reports received from biologics manufacturers with a focus on pre-licensing establishments and products. 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. On own initiative or through verbal instruction, composes and/or prepares correspondence, memoranda, reports, forms, and other material for CVB officials, biologics manufacturers, and others. Report to supervisor on performance, progress and training needs of employees, and on behavior problems.

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 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 time-in-grade restrictions, specialized experience and/or education, as defined below. TIME-IN-GRADE: Current federal employees applying for a promotion opportunity must meet time-in-grade (TIG) requirement of 52 weeks of service at the next lower grade level in the normal line of progression for the position being filled. FOR THE GS-08 LEVEL: Applicants must have one year of specialized experience (equivalent to the GS-07 level) that may have been obtained in the private or public (local, county, state, Federal) sectors which demonstrates: Utilizing a database to collect and report biological workload data such as the Licensing Serial Release and Testing System (LSRTIS). Determining validity, completeness, and accuracy of furnished biologics documentation to determine acceptability. 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 in a tracking system, records management system, or making notations in a file. Coordinating and prioritizing workload to ensure timely accomplishment and adequate distribution of workload. 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]

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