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.
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.
Status Candidates (this includes Merit Promotion, Former Overseas Employees, CTAP, ICTAP, VEOA, 30% or More Disabled Veterans, Schedule A, Military Spouses, Americorps, Peace Corps, Vista, USPHS officers and officer candidates, Land Management, and Interchange Agreement Eligibles)
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.
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.
Must meet time in grade requirements.
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.
Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the "percentage of times" the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
NOTE: 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.
Time-in-Grade Requirement: Under competitive merit promotion procedures, any individual who is currently holding, or who has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet "time-in-grade" requirements (have served 52 weeks at the next lower grade of the grade for which you are applying). You must include an SF-50 (you may need to submit more than one) that supports meeting this requirement with your application package.
All qualification requirements must be met by the closing date of the announcement.
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.
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.
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
"All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment."
Veterans Employment Opportunities Act (VEOA): To be eligible for a VEOA appointment under Merit Promotion consideration, the veteran must be: 1) a preference eligible; or 2) a veteran separated after 3 or more years of continuous active service performed under honorable conditions (you must submit a DD214-member copy 4).
PHS Commissioned Corps (CC) Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred as CC personnel and not as candidates for conversion to a permanent career or career-conditional appointment. You must provide a copy of your current personnel orders and/or other supporting documentation to be referred as CC.
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
Career Transition Program: This program applies to Federal service employees whose positions have been deemed surplus or no longer needed, or employees who have been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must: 1) meet eligibility criteria for CTAP or ICTAP; 2) be rated well-qualified for the position; and 3) submit the appropriate documentation to support your CTAP or ICTAP eligibility. Well-Qualified includes those applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements for the position. For information on eligibility criteria and required documentation, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp
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.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
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.
For Competitive Merit Promotion and Veterans Employment Opportunities Act (VEOA) Applicants: The highest rated candidates will be referred to the hiring agency.
For Noncompetitive Applicants: All qualified candidates will be referred to the hiring agency.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
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.
If you are a current Federal employee, you must submit a copy of your Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status.
You may need to submit more than one SF-50 to demonstrate that you meet time-in-grade requirements. Recommended SF-50s include: promotions and step increases (within grade increases).
If you are a former Federal employee, you must submit a copy of your separation Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status. .
If you are a former Federal employee who previously held a career or career-conditional position in the competitive service, separated from the Federal Government over a year ago, and your last performance rating on record as a Federal employee was at least Fully Successful (or equivalent), you must submit a copy of your separation Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status AND your last Federal performance appraisal plan.
Other required supporting documents.
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.
CTAP/ICTAP 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.
PHS Commissioned Corps Personnel Orders or other supporting documentation
Documentation supporting eligibility for non-competitive appointment, (severely disabled, eligible veterans, certain military spouses, etc.)
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:
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.
To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section.
*To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.
*Click the Submit My Answers button to submit your application package.
*It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
To verify your application is complete, log into your USAJOBS account at https://my.usajobs.gov/Account/Login, select the Application Status link, and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
To return to an incomplete application, log into your USAJOBS account at https://my.usajobs.gov/Account/Login and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
The complete Application Package must be submitted by 11:59 PM (EST) on 10/22/2021.
Assistant Secretary for Preparedness and Response
200 Independence Ave. SW
Washington, DC 20201
US
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The best qualified candidates will be referred to the hiring manager for further consideration and possible interview.
You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed. You will be required to submit official documentation prior to appointment. The agency will then verify the information provided on your application (i.e., degree, veterans' preference, disability, etc.).
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
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.
If you are a current Federal employee, you must submit a copy of your Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status.
You may need to submit more than one SF-50 to demonstrate that you meet time-in-grade requirements. Recommended SF-50s include: promotions and step increases (within grade increases).
If you are a former Federal employee, you must submit a copy of your separation Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status. .
If you are a former Federal employee who previously held a career or career-conditional position in the competitive service, separated from the Federal Government over a year ago, and your last performance rating on record as a Federal employee was at least Fully Successful (or equivalent), you must submit a copy of your separation Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status AND your last Federal performance appraisal plan.
Other required supporting documents.
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.
CTAP/ICTAP 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.
PHS Commissioned Corps Personnel Orders or other supporting documentation
Documentation supporting eligibility for non-competitive appointment, (severely disabled, eligible veterans, certain military spouses, etc.)
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:
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.
To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section.
*To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.
*Click the Submit My Answers button to submit your application package.
*It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
To verify your application is complete, log into your USAJOBS account at https://my.usajobs.gov/Account/Login, select the Application Status link, and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
To return to an incomplete application, log into your USAJOBS account at https://my.usajobs.gov/Account/Login and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
The complete Application Package must be submitted by 11:59 PM (EST) on 10/22/2021.
Assistant Secretary for Preparedness and Response
200 Independence Ave. SW
Washington, DC 20201
US
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The best qualified candidates will be referred to the hiring manager for further consideration and possible interview.
You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed. You will be required to submit official documentation prior to appointment. The agency will then verify the information provided on your application (i.e., degree, veterans' preference, disability, etc.).
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
