Duties

Summary

This position is located in the Department of Health and Human Services, Office of the Secretary of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), Division of Regulatory and Quality Affairs, located in District of Columbia, District of Columbia.

*This announcement will remain open for 10 business days OR until the first 75 applications have been received, whichever occurs first*
Learn more about this agency

Responsibilities

• Serving as a lead representative determining quality acceptability of medical countermeasures products delivered to operational designated storage facilities.
• Executing the receiving, inspection, and acceptance process for medical countermeasures product delivered to operational designated storage Current Good Manufacturing Practice (cGMP) manufacturing facilities.
• Developing and implementing regulatory decisions, procedures and staff guidance to assigned activities as required by statues, regulations, and operational requirements.
• Reviewing and evaluating all documentation related to product inspection and acceptance in United States Government (USG) product acceptance system such as batch records, doses quantity, etc.
• Maintaining technical surveillance over government operations required to support the program goals and objectives of assigned actions.
• Serving as a Lead Quality representative that trains all regulatory QA personnel on the product inspection and acceptance system.
• Providing support to the development, organization, maintenance of SOPS, internal quality documentation, files, records and quality databases.

Travel Required

Occasional travel - You may be expected to travel up to 20% for this position.

Supervisory status
No

Promotion Potential
None

Requirements

Conditions of Employment

• U.S. Citizenship required
• Registered or exempt from Selective Service (www.sss.gov)
• If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.
• One year probationary period may be required
• If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.
• All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choice.
• Financial disclosure statement may be required.
• Bargaining Unit Position: No
• Drug Screening Required: Yes
• Research position: No

Qualifications

Applicants must demonstrate that they meet the Specialized Experience requirements as noted below.

Specialized Experience:
GS-14: You must possess at least one year of specialized experience equivalent in difficulty and responsibility to the GS-13 level in the Federal service that includes the following:

• Managing, scheduling and integrating product inspection and acceptance in medical countermeasures products such as vaccines, therapeutics, etc.
• Interpreting and applying Current Good Manufacturing Practice (cGMP) regulations and guidance with understanding of the approach and perspectives of regulatory product acceptance
• Executing the receiving, inspection, and acceptance process for medical countermeasures product delivered to operational designated storage manufacturing facilities
• Reviewing and evaluating documentation related to product inspection and acceptance in United States Government (USG) product acceptance system

NOTE(s):

• Experience: Your resume must support your claim of experience or you may be found ineligible.

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; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.

All qualification requirements must be met by the closing date of the announcement.

In accordance with Executive Order 14043 , Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement.

NOTE: During the COVID-19 pandemic you may be authorized to telework remotely. The Federal government will begin a phased transition to normal operations in line with the national guidelines to Open Up America Again. HHS will make operating decisions based on State or locality of duty stations and other factors.

Education

Education may not be used or combined to qualify for this position.

Additional information

INCENTIVES
Incentives may be authorized; however, this is contingent upon multiple factors, including funds availability. If authorized, certain incentives may require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives may include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.

"All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment."

In accordance with Executive Order 12564 of September 14, 1986, The Department of Health and Human Services (HHS) is A Drug-Free Federal Workplace. The use of illegal drugs, on or off duty, by Federal employees is inconsistent not only with the law-abiding behavior expected of all citizens, but also with the special trust placed in such employees as servants of the public.

Veterans' Preference - https://www.fedshirevets.gov/job/vetpref/index.aspx

Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please see Agency Contact Information for whom to contact for more info. The decision on granting reasonable accommodation will be made on a case-by-case basis. You must contact the HR contact on the vacancy announcement at least three business days before the closing date of this announcement to receive assistance. For more information on disability employment, please visit https://www.opm.gov/policy-data-oversight/disability-employment/

Selective Service: Males born after December 31, 1959 must be registered or exempt from Selective Service - http://www.sss.gov

Interagency Career Transition Assistance Program (ICTAP): For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap . To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.

Political appointment: Beginning January 1, 2010, agencies must seek prior approval from OPM before they can appoint a current or recent political appointee to a competitive or non-political excepted service position at any level under the provisions of title 5, United States Code. If you are currently, or have been within the last 5 years, a political Schedule A, Schedule C, or Non-career SES employee in the executive branch, you MUST disclose that to the Human Resources Office.

If you are unable to apply online, please go to https://help.usastaffing.gov/Apply/index.php?title=Alternate_Application_Information for more information on our alternate application method.

How You Will Be Evaluated

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

Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.

Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility. Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of three categories:

• Best Qualified - Applicants who have experience that is almost identical to those required by the position.
• Well Qualified - Applicants who have experience that is very similar to those required by the position.
• Qualified - Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.

Candidates in the highest category will be referred to the hiring agency.

The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):

• Communication
• Planning and Evaluating
• Quality Assurance
• Technical Credibility

To preview the assessment questionnaire, click the following link: https://apply.usastaffing.gov/ViewQuestionnaire/11231405

Background checks and security clearance

Security clearance
Other

Drug test required
Yes

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Suitability/Fitness , Credentialing

Required Documents

Submission of a resume alone IS NOT a complete application. You must provide a complete online Application Package which includes:

• Your Resume must clearly articulate how your skills and experiences align to the criteria defined in the qualifications section of this announcement and it must support your responses to the assessment questionnaire. For each position you must describe your duties, accomplishments, related skills, and responsibilities. Your resume must also include the day, month, and year that you began and ended as well as hours worked per week (if less than 40) for each position held. Full-time employment will be assumed unless otherwise stated on your resume. Part-time employment will be prorated in crediting experience. Not providing this information may result in the lowering of your assessment score or an ineligible rating. For resume writing guidance, please visit the USAJobs Resource Center or view their video tutorial .
• A complete Assessment Questionnaire ( https://apply.usastaffing.gov/ViewQuestionnaire/11231405 )

Other Supporting Documents: (Only Submit if applicable to you.)

• Veterans' Preference documentation:
  • Discharged Veterans: If you are claiming 5 point preference, you must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that supports dates of service and discharge status; if claiming 10 point preference, an application for 10-Point Veterans Preference (SF-15) and an official document dated 1991 or later, from the Department of Veterans Affairs or from a branch of the Armed Forces, and/or any other associated documentation based on your preference.
  • Active Duty Members: Under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, if claiming 5 point preference, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• ICTAP/CTAP Documentation:
  • A copy of your RIF separation notice, notice of proposed removal for failure to relocate, notice of disability annuity termination, or certification from the National Guard Bureau or Military Department that you are eligible for disability retirement;
  • A copy of your SF-50 "Notification of Personnel Action'', documenting your RIF separation, noting your positions, grade level, and duty location, and/or Agency certification of inability to place you through RPL, etc;
  • A copy of your latest performance appraisal including your rating; and
  • Any documentation from your agency that shows your current promotion potential.
• Are you a current or former political Schedule A, Schedule C, Non-career SES or Presidential Appointee employee? Submit a copy of your applicable SF-50, along with a statement that provides the following information regarding your most recent political appointment:
  • Position title;
  • Type of appointment (Schedule A, Schedule C, Non-career SES, or Presidential Appointee);
  • Agency; and
  • Beginning and ending dates of appointment.

You are not required to submit official documents at this time; copies are sufficient.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.