Duties

Summary

The Quality Assurance Specialist performs quality control activities during the receipt, storage, handling, transport, and distribution of pharmaceutical products ensuring Good Manufacturing Practice (cGMP) standards are adhered to by Veterinary Services, Field Operations Logistics Center (FiOps LC) staff and contract partners.

This is a Term Appointment not-to-exceed 13 months. The appointment may be extended up to 4 years.
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Responsibilities

• The duties described are for the full-performance level. At developmental grade levels, assignments will be of more limited scope, performed with less independence and limited complexity.
• The duties may include, but are not limited to:
• Identifying deficiencies and advising manufacturers of corrective actions needed, and recommends acceptance or rejection of the manufacturer's quality system
• Assisting in the development and implementation of program systems, policies and procedures to ensure product quality and compliance with cGMP standards and other regulatory requirements
• Conducting regular audits of FiOps LC repositories and contract partner operations to ensure product is managed appropriately and issues written audit findings
• Serving as a subject matter expert in subject areas related to pharmaceutical quality assurance, FDA cGMP regulations, and the storage and handling requirements of products in the National Veterinary Stockpile/ APHIS warehouse
• Leading the administration of the Quality Assurance program providing technical guidance to management and staff personnel
• Leading the analysis of quality data and reporting on the quality level achieved in supply and storage operations

Travel Required

25% or less - You will be expected to travel for this position (25 percent or more of the time)

Supervisory status
No

Promotion Potential
None

Requirements

Conditions of Employment

• You must be a US Citizen or US National.
• Males born 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/
• In accordance with Office of Government Ethics regulations concerning conflict of interest, the incumbent will be required to submit a financial disclosure report within 30 days of their effective date of appointment and annually thereafter.
• Must be able to lift up to 50 lbs. Does require significant travel and frequent visits to warehouse environments where long-term standing, reaching, and bending are required.
• Must be available on a 24-hour basis, including weekends, year-round.
• This is a term appointment not-to-exceed 13 months.

Qualifications

Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement, including specialized experience, as defined below.

FOR THE GS-13 LEVEL: Applicants must have one year of specialized experience (equivalent to the GS-12 level) that may have been obtained in the private or public (local, county, state, Federal) sectors which demonstrates: 1) Developing/implementing or assisting in the developing/implementing program systems, policies and/or procedures to ensure product quality and compliance with Good Manufacturing Practice (cGMP) standards or other related regulatory requirements; 2) Conducting audits of veterinary service centers (e.g. Veterinary Services, Field Operations Logistics Center/FiOps LC repositories) and/or contract partner operations to ensure product is managed appropriately and issues written audit findings; 3) providing veterinary quality control technical guidance to management and/or staff personnel; AND 4) Identifying deficiencies and advising manufacturers of corrective actions needed, and/or recommending acceptance or rejection of the manufacturer's quality system.

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), Reemployment Priority List (RPL), or Interagency Career Transition Assistance Plan (ICTAP): Visit the OPM website for information on how to apply as a CTAP, RPL, or ICTAP eligible. To exercise selection priority for this vacancy, CTAP/RPL/ICTAP candidates must meet the basic eligibility requirements and all selective factors. CTAP/ICTAP 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/ICTAP 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 eligible for telework within the local commuting area of the duty location of the position. Employee participation is at the discretion of the supervisor.
• Locality pay will vary based upon the selectee's duty location. A final salary determination will be made upon selection.
• This is a term appointment not-to-exceed 13 months. (Appointment may be extended up to 4 years without re-announcing). For more details click: Term Appointments
• The work is typically performed in an office setting. However, the employee regularly reviews and inspects product and facilities that include storage warehouses with refrigeration and freezers as low as -30 degrees Celsius. Protective clothing and observance of safety precautions are required. In addition, the incumbent may be required to have special immunizations and use appropriate protective clothing during facility inspections.
• This individual must be able to travel 25 percent or more of the time using government, domestic, and/or foreign modes of air, land, and/or sea transportation; and must be available on a 24-hour basis, including weekends, year-round.
• Must carry a government issued cell phone at all times and respond when needed.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Applications will be evaluated in accordance with Office of Personnel Management's (OPM) Delegated Examining Procedures and USDA policy using category rating. Applicants who meet basic minimum qualifications will be placed in one of three categories: Best Qualified, Well Qualified, or Qualified. Within these categories, applicants eligible for veteran's preference will receive selection priority over non-veterans. Category placement will be determined based on applicants' quality of experience and the extent they possess the following knowledge, skills, and abilities (KSA) or competencies:

• Quality Assurance
• Quality Management

Your application, including the online Assessment Questionnaire, will be reviewed to determine if you meet (a) minimum qualification requirements and (b) the resume supports the answers provided to the job-specific questions. Your resume must clearly support your responses to all the questions addressing experience and education relevant to this position. Those determined to be in the best qualified category will be referred to the selecting official for consideration.

Note: If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your score may be adjusted to more accurately reflect your abilities, or you may be found ineligible. Please follow all instructions carefully. Errors or omissions may affect your rating. Providing inaccurate information on Federal documents could be grounds for non-selection or disciplinary action up to including removal from the Federal service.

To preview the application questionnaire, please visit: https://apply.usastaffing.gov/ViewQuestionnaire/10954130

Background checks and security clearance

Security clearance
Secret

Drug test required
No

Position sensitivity and risk
Noncritical-Sensitive (NCS)/Moderate Risk

Trust determination process
Credentialing , Suitability/Fitness , National security

Required Documents

The following documents are required for your applicant package to be complete. Our office cannot be responsible for incompatible software, your system failure or downtime, etc. Encrypted documents will not be accepted. Failure to submit required, legible documents may result in loss of consideration.

• Resume that includes: 1) personal information such as name, address, contact information; 2) education; 3) detailed work experience related to this position as described in the major duties including work schedule, hours worked per week, dates of employment; title, series, grade (if applicable); 4) other qualifications; and 5) supervisors name and phone number for each work period listed and whether or not they may be contacted for reference checks.
• If claiming veterans' preference, you must submit a DD214, Certificate of Release from Active Duty, which shows dates of service and discharge under honorable conditions. If currently on active duty you must submit a certification of expected discharge or release from active duty service under honorable conditions within 120 days after the date the certification is submitted. The certification must be on the letterhead of the appropriate military branch and include the dates of military service. Veterans' preference must be verified prior to appointment. Without this documentation, you will not receive veteran's preference and your application will be evaluated based on the material(s) submitted.
• If claiming 10-point veterans' preference you must provide the DD214 or certification requirements (see above bullet), plus the proof of entitlement of this preference as listed on the SF-15 Application for 10-point Veterans' Preference. The SF-15 should be included but is not required. Failure to submit these documents could result in the determination that there is insufficient documentation to support your claim for 10-point preference. For more information on veterans' preference visit FEDSHIREVETS
• Surplus or displaced employees eligible for CTAP, RPL, or ICTAP priority must provide: proof of eligibility (RIF separation notice, notice of proposed removal for declining a transfer of function or directed reassignment to another commuting area, notice of disability annuity termination), SF-50 documenting separation (as applicable), last performance appraisal that is at least fully successful or its equivalent, and your most recent SF-50 noting position, grade level, and duty location with your application per 5 CFR 330.
• Worker's Compensation Separation: Agency certification of inability to place employee AND Notification of Separation OR Separation SF-50.
  • Disability Annuity Termination: Notification from OPM of disability annuity termination AND Separation SF-50 of the last position held. Military Reserve or National Guard Technician Special Disability Retirement Annuity under 5 U.S.C. 8337(h) or 8456: Certification of special disability retirement annuity from a military department or National Guard Bureau AND Separation SF-50 of the last position held.