- Position Title
- Quality Assurance Specialist
- Agency
- Office of the Secretary of Health and Human Services
- Announcement Number
- HHS-ASPR-MP-21-11231406 Opens in new window
- Open Period
- Monday, October 11, 2021 to Friday, October 22, 2021
For preview purposes only. To apply, please return to the USAJOBS announcement and click the Apply button.
Eligibilities
PLEASE READ THE FOLLOWING ELIGIBILITY QUESTIONS CAREFULLY. YOUR RESPONSES WILL AFFECT YOUR CONSIDERATION FOR THIS POSITION.
The following questions address if you are eligible to apply to this job opportunity announcement through Merit Promotion procedures. You will only be considered under the options you have selected, so please choose carefully. If you respond that you do not meet any of the following criteria, you will not be considered for this position under this announcement. Please refer to the announcement for additional information. If you still have questions concerning your eligibility for consideration, you may reach out to the contact in the announcement prior to the announcement closing. You must submit a complete application by the close of the announcement to be considered.
The following questions address if you are eligible to apply to this job opportunity announcement through Merit Promotion procedures. You will only be considered under the options you have selected, so please choose carefully. If you respond that you do not meet any of the following criteria, you will not be considered for this position under this announcement. Please refer to the announcement for additional information. If you still have questions concerning your eligibility for consideration, you may reach out to the contact in the announcement prior to the announcement closing. You must submit a complete application by the close of the announcement to be considered.
1.
Do you claim Veterans' Preference?
2.
Are you a veteran who separated from active duty under honorable conditions and you:
For more information, review USAJOBS Veterans resources. (https://www.usajobs.gov/Veterans)
- have a rating by the Department of Veterans Affairs showing a compensable service-connected disability of 30% or more OR
- retired from active military service with a service-connected disability rating of 30% or more
For more information, review USAJOBS Veterans resources. (https://www.usajobs.gov/Veterans)
3.
Are you a current or former federal employee displaced from the Department of Health and Human Services? If yes, confirm:
• You are located in the same local commuting area of the vacancy
• Your grade is equivalent to or above the grade level of the vacancy AND
• Your last performance rating of record is at least fully successful or the equivalent.
You will be required to submit supporting documentation to validate your claim of CTAP eligibility such as a Reduction in Force (RIF) separation notice or a Proposed Removal/Separation notice and a copy of your latest Notification of Personnel Action, Standard Form 50. For more information, review the USAJOBS Resource Center page (https://www.usajobs.gov/Help/working-in-government/unique-hiring-paths/federal-employees/ctap/).
• You are located in the same local commuting area of the vacancy
• Your grade is equivalent to or above the grade level of the vacancy AND
• Your last performance rating of record is at least fully successful or the equivalent.
You will be required to submit supporting documentation to validate your claim of CTAP eligibility such as a Reduction in Force (RIF) separation notice or a Proposed Removal/Separation notice and a copy of your latest Notification of Personnel Action, Standard Form 50. For more information, review the USAJOBS Resource Center page (https://www.usajobs.gov/Help/working-in-government/unique-hiring-paths/federal-employees/ctap/).
4.
Are you currently employed as a Federal civilian employee in the Competitive Service AND have you never held the full performance level of this position?
-- OR --
Were you formerly employed as a Federal civilian employee on a permanent competitive appointment or did you obtain career-conditional status (and are within 3 years of the date of separation or are a preference eligible) AND have you never held the full performance level of this position?
-- OR --
Are you currently employed as a civilian employee in the competitive service that holds a career or career-conditional position at a lower grade level than the position being announced?
To verify your eligibility as a current or former Federal civilian employee:
You must submit a copy of your SF-50: Notification of Personnel Action or equivalent personnel action form reflecting your permanent, competitive status.
Your SF-50 must reflect:
-- OR --
Were you formerly employed as a Federal civilian employee on a permanent competitive appointment or did you obtain career-conditional status (and are within 3 years of the date of separation or are a preference eligible) AND have you never held the full performance level of this position?
-- OR --
Are you currently employed as a civilian employee in the competitive service that holds a career or career-conditional position at a lower grade level than the position being announced?
To verify your eligibility as a current or former Federal civilian employee:
You must submit a copy of your SF-50: Notification of Personnel Action or equivalent personnel action form reflecting your permanent, competitive status.
Your SF-50 must reflect:
- career or career-conditional (Tenure field is 1 or 2); AND
- status in the competitive service (Position Occupied field is 1).
5.
Are you a current or former federal employee displaced from a position in a federal agency other than the agency hiring for this position?
If yes, confirm:
For more information, review the USAJOBS Resource Center. (https://www.usajobs.gov/Help/working-in-government/unique-hiring-paths/federal-employees/ictap/)
If yes, confirm:
- you are located in the same local commuting area of the vacancy
- your grade is equivalent to or below the grade level of the vacancy and
- your last performance rating of record is at least fully successful or the equivalent.
For more information, review the USAJOBS Resource Center. (https://www.usajobs.gov/Help/working-in-government/unique-hiring-paths/federal-employees/ictap/)
6.
Are you a current or former employee of a land management agency (Forest Service; Bureau of Land Management; National Park Service; Fish and Wildlife Service; Bureau of Indian Affairs; or Bureau of Reclamation) who:
- was originally hired to a time-limited position under a competitive appointment; AND,
- served one or more time-limited appointments at a land management agency for a period totaling more than 24 months without a break in service of two or more years; AND,
- performed at an acceptable level of service during each period of service; AND,
- if no longer employed by the land management agency, have been separated for no more than two years, and departed that position in good standing.
7.
Are you currently employed as a Federal civilian employee in the Competitive Service at the same grade level as this position or higher with the same or higher promotion potential?
To verify your eligibility as a current Federal civilian employee, you must submit a copy of your latest Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status.
Are you a former Federal employee who previously held a career or career-conditional position in the competitive service with equal or higher promotion potential as the position being announced?
To verify your eligibility as a former Federal civilian 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.
Are you 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)?
To verify your eligibility as a former Federal civilian 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 AND your last Federal performance appraisal plan.
Your SF-50 (or equivalent personnel action form) must reflect:
To verify your eligibility as a current Federal civilian employee, you must submit a copy of your latest Notification of Personnel Action, Standard Form 50 (SF-50) or equivalent personnel action form reflecting your permanent, competitive status.
- career or career-conditional (Tenure field is 1 or 2); AND
- status in the competitive service (Position Occupied field is 1).
Are you a former Federal employee who previously held a career or career-conditional position in the competitive service with equal or higher promotion potential as the position being announced?
To verify your eligibility as a former Federal civilian 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.
- career or career-conditional (Tenure field is 1 or 2); AND
- status in the competitive service (Position Occupied field is 1).
Are you 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)?
To verify your eligibility as a former Federal civilian 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 AND your last Federal performance appraisal plan.
Your SF-50 (or equivalent personnel action form) must reflect:
- career or career-conditional (Tenure field is 1 or 2); AND,
- your status is in the competitive service (Position Occupied field is 1).
- Rating of Fully Successful (or equivalent)
8.
Do you meet one of the following Non-Competitive Merit Promotion Eligibilities:
Individuals eligible under other non-competitive appointment authorities such as: Certain Military Spouses, Peace Corps/VISTA, excepted service employees who are eligible under an Interchange Agreement, Foreign Service Employees, Certain Former Overseas Employees, Boren Fellows, Former White House staff, etc. Note: You must submit documentation to support any eligibilities for which you wish to be considered.
Individuals eligible under other non-competitive appointment authorities such as: Certain Military Spouses, Peace Corps/VISTA, excepted service employees who are eligible under an Interchange Agreement, Foreign Service Employees, Certain Former Overseas Employees, Boren Fellows, Former White House staff, etc. Note: You must submit documentation to support any eligibilities for which you wish to be considered.
9.
Do you have a severe physical, psychiatric or mental disability that qualifies you for Schedule A Disability appointments?
If eligible, provide proof of disability with appropriate medical documentation, i.e., a letter signed by a licensed medical professional or licensed vocational rehabilitation specialist stating your condition and restrictions.
For more information, review USAJOBS Individuals with Disabilities resources. (https://www.usajobs.gov/Help/working-in-government/unique-hiring-paths/individuals-with-disabilities/)
If eligible, provide proof of disability with appropriate medical documentation, i.e., a letter signed by a licensed medical professional or licensed vocational rehabilitation specialist stating your condition and restrictions.
For more information, review USAJOBS Individuals with Disabilities resources. (https://www.usajobs.gov/Help/working-in-government/unique-hiring-paths/individuals-with-disabilities/)
10.
Are you a current United States Public Health Service Commissioned Corps Officer or a United States Public Health Service Commissioned Corps Officer candidate?
If yes:
If yes:
- For current active duty USPHS Commissioned Corps officers, submit a copy of your most recent personnel orders.
- For USPHS Commissioned Corps candidates, submit documentation from the Division of Commissioned Corps Personnel and Readiness (DCCPR) stating you have successfully completed the professional boarding process.
11.
Are you a veteran whose latest discharge was under honorable conditions and you:
• served three or more years of continuous active duty service in the military (NOTE: if released shortly before completing a 3-year tour, you are considered to meet the eligibility)? OR
• are entitled to veterans' preference?
If eligible, submit a copy of your latest Certificate of Release or Discharge from Active Duty, DD-214 (copy indicating character of service) or other proof of your service which includes character of service. For more information, review USAJOBS Veterans resources.
• served three or more years of continuous active duty service in the military (NOTE: if released shortly before completing a 3-year tour, you are considered to meet the eligibility)? OR
• are entitled to veterans' preference?
If eligible, submit a copy of your latest Certificate of Release or Discharge from Active Duty, DD-214 (copy indicating character of service) or other proof of your service which includes character of service. For more information, review USAJOBS Veterans resources.
12.
In the last five years, based on the closing date of this announcement, have you been or are you currently an employee in the Executive Branch serving on a political, Schedule C, or Non-career SES appointment?
You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed.
If yes, and you are selected through this vacancy announcement, you may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.
You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed.
If yes, and you are selected through this vacancy announcement, you may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.
- A political appointee is an appointment made by the President without confirmation by the Senate (5 CFR 213.3102(c)) OR an Assistant position to a top-level Federal official if filled by a person designated by the President as a White House Fellow (5 CFR 213.3102(z)).
- A Non-career SES appointee is approved by the White House and serves at the pleasure of the appointing official without time limitations.
- A Schedule C appointee occupies a position excepted from the competitive service by the President, or by the Director, OPM, because of the confidential or policy-determining nature of the position duties.
Assessment 1
Select “Yes” or “No” to the following question(s).
1.
Do you possess at least one full year of specialized experience comparable in scope and responsibility to the GS-13 level in the Federal service(obtained in either the public or private sectors): 1) Managing, scheduling and integrating product inspection and acceptance in medical countermeasures products such as vaccines, therapeutics, etc.; 2) Interpreting and applying Current Good Manufacturing Practice (cGMP) regulations and guidance with understanding of the approach and perspectives of regulatory product acceptance; 3) Executing the receiving, inspection, and acceptance process for medical countermeasures product delivered to operational designated storage manufacturing facilities; and 4) Reviewing and evaluating documentation related to product inspection and acceptance in United States Government (USG) product acceptance system?
Select the one statement that most accurately describes your training and experience carrying out each task using the scale provided.
2.
Provide expertise in managing on-site inspections and acceptance at operational of Current Good Manufacturing Practice (cGMP) manufacturing storage facilities.
3.
Manage, schedule and perform routine on-site inspection and acceptance.
4.
Conduct manufacturing facility/site product inspection and acceptance for regulatory compliance.
5.
Provide recommendations to accept or reject product shipment.
6.
Audit documentation for tracking medical countermeasures products against received quantities and manages resolution of differences.
7.
Implement tracking system where all documentation records of product inspection and acceptance are stored while meeting all deliverables and timelines.
8.
Utilize the quality assurance principles and methods for the development of organization quality assurance plans, policies, and procedures to conduct staff studies of complex or unprecedented quality assurance problems.
9.
Implement and modify Quality Assurance processes and supporting technology solutions that have immediate and direct effects on organizations and ongoing Quality Assurance programs.
10.
Review results of quality review of the receipt and inspection and acceptance process.
11.
Provide the analysis and resolution of very complex or sensitive quality assurance problems.
12.
Analyze and provide resolution for new developments and methodologies for assigned program areas.
13.
Evaluate and analyze Federal statutes, policies and regulations to develop new techniques and procedures.
14.
Write and revise standard operating procedures (SOPS) as required for product inspection and acceptance for drugs and biologics delivered to operation designated storage facilities.
15.
Effectively interact with diverse teams to identify opportunities to improve product inspection and acceptance and resolve quality assurance issues.
16.
Present product inspections, acceptance and finalized deviations to management.
17.
Develop organization quality assurance plans, policies, and procedures to conduct staff studies of complex or unprecedented quality assurance problems.