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Summary 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. Responsibilities 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 Conditions of Employment 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. Additional Information Career Transition Assistance Plan (CTAP) or Reemployment Priority List (RPL): Visit the OPM website for information on how to apply as a CTAP or RPL eligible. To exercise selection priority for this vacancy, CTAP/RPL candidates must meet the basic eligibility requirements and all selective factors. CTAP candidates must be rated and determined to be well qualified (or above) based on an evaluation of the competencies listed in the How You Will Be Evaluated section. When assessed through a score-based category rating method, CTAP applicants must receive a rating of at least 85 out of a possible 100. First time hires to the federal government normally start at the lowest rate of the salary range for the grade selected. Travel, transportation, and relocation expenses will not be paid. Any travel, transportation, and relocation expense associated with reporting for duty will be the responsibility of the selected employee. This position is represented by a collective bargaining unit (union), specifically the American Federation of Government Employees (AFGE) Local 2315. Worksite Information: This position may be eligible to telework up to four days per week, based upon the duties of the position. This position may also be eligible for flexible work arrangements as determined by agency policy and any applicable collective bargaining agreements. Additional information regarding ad hoc, occasional, or reoccurring telework may be obtained at a later time from the hiring manager or program during the hiring process.
