Quality Assurance Specialist
Department of Health and Human Services, ASPR Department of Health and Human Services, ASPR Atlanta, GA Atlanta, GA Full-time Full-time $122,907 - $159,776 a year $122,907 - $159,776 a year 15 hours ago 15 hours ago 15 hours ago Link to Announcement:
(MP):
https:
//www.
usajobs.
gov/job/731273800 Duties As a Quality Assurance Specialist you will:
Responsible for the development, coordination, and implementation of the Quality Management Plan (QMP) for the Strategic National Stockpile.
Ensure that the plan and associated guidelines and established procedures are consistent with federal regulation and the provisions of the Food and Drug Administration's current Good Manufacturing Practice (cGMP) standards.
Serve as the subject matter expert in development of Quality Management Systems (QMS) that support quality assurance efforts.
Develop operating criteria and procedures, staff and operational standards and protocols.
Review quality assurance audit findings, identifies compliance and deficiency issues that are critical or resistant to control, assesses programmatic impact and develops alternative methods or approaches for inclusion in the QMP.
Coordinate the resolution of issues related to the QMS components, including planning, implementation, and evaluation of process improvement tools utilized.
Serve as a senior expert and advisor to management for quality assurance program management issues affecting the national stockpile.
Participates actively in planning efforts to improve organizational reliability and responsiveness.
Provide technical advice to other agencies and organizations and serves on interagency boards, special committees or task groups concerned with quality assurance issues.
Conduct audits of SNS facilities and contract partner operations to document compliance with program requirements, identify deficiencies, and ensure that corrective and preventive actions and maintenance goals are being met.
Plan work to be accomplished by subordinates, sets and adjust short-term priorities, prepares schedules for completion of work, when necessary.
Assign work to subordinates based priorities, considering difficulty and requirements of assignments as well as the capabilities of employees.
Gives advice, counsel, or instruction to employees on both work and administrative matters.
Convenes interview panels for candidates for positions in the work unit.
Recommends appointment, promotion or reassignment of employees to supervisor.
Hears and resolves complaints from employees, referring group grievances and more serious unresolved complaints to a higher-level supervisor.
Help Requirements Conditions of Employment US Citizenship is required.
Background Investigation may be required.
One-year probationary period may be required.
Travel, transportation, and moving expenses will be paid:
No Bargaining Unit Position:
No Drug Screening Required:
No Promotion potential:
No Supervisory position:
Yes:
This position has 20% supervisory duties, candidates must also have demonstrated or shown the potential to develop the necessary knowledge, skills, and abilities.
Applicants should describe any previous experience or responsibilities which could be used in relation to the supervisory requirements of this position.
Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
All qualification requirements must be met by the closing date of the announcement.
Public Trust/Moderate Background Investigation (5) is required.
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 Federal government, as the largest employer in the Nation, can and should show the way towards achieving drug-free workplaces through programs designed to offer drug users a helping hand, and at the same time demonstrating to drug users and potential drug users that drugs will not be tolerated in the 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.
Applicants tentatively selected for this position may be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to reasonable suspicion and post-accident drug testing upon hiring.
If required to submit to urinalysis, the appointment to the position will be contingent upon a negative applicant drug test result.
In order to demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.
Qualifications Minimum
Qualifications:
Applicants must have one year of specialized experience at or equivalent to the GS-13 grade level of in the Federal service as defined in the next paragraph.
Specialized experience is experience which is directly related to the position which has equipped the applicant with the particular knowledge, skills and abilities (KSAs) to successfully perform the duties of the position to include experience providing guidance and advisory services to management and program staff on policies, processes, and procedures related to working in public health emergency preparedness programs at the federal, state, tribal, local, or territorial level.
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.
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, knowledge, and skills 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 job does not have an education qualification requirement.
Additional information Additional selections may be made within the same geographical location CDC-wide.
Males born after December 31, 1959 must be registered or exempt from Selective Service (see http:
//www.
sss.
gov).
To view the questionnaire, click on the following link:
https:
//apply.
usastaffing.
gov/ViewQuestionnaire/11998581 If you are unable to apply online, please contact the CDC Helpdesk by phone (770) 488-1725 or email HRCS@CDC.
GOV.
Applicants are strongly encouraged to apply online.
Applying online, through your USAJOBS account, will expedite the application process and allow you to check your application.
If you utilize the Alternate Application method, your USAJOBS account will not display this application or status updates related to this application.
Positions may be available in multiple locations across the United States, or eligible for telework and remote work opportunities, based on the Center for Disease Control and Prevention's (CDC's) Workplace Flexibilities Policy.
To Remain An Active Duty USPHS Commissioned Corps OfficerJoin more than 6,500 highly qualified public health professionals as part of the U.
S.
Public Health Service.
Overseen by the Surgeon General, you will be part of an elite and diverse team of professionals essential to public health leadership and exemplary clinical service.
PHS Officers interested in performing the duties of this position with the Commissioned Corps, you are welcome to apply and receive a courtesy referral.
Note that a courtesy referral is not a competitive civil service process and does not provide civil service status for the selected employee.
Click Herefor the comparison chart of Commissioned Corps ranks to civil service, which advises you on potential billet rankings.
Job Type:
Full-time Pay:
$122,907.
00 - $159,776.
00 per year Schedule:
8 hour shift Day shift Monday to Friday Work setting:
In-person Ability to commute/relocate:
Atlanta, GA:
Reliably commute or planning to relocate before starting work (Required) Shift availability:
Day Shift (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
(MP):
https:
//www.
usajobs.
gov/job/731273800 Duties As a Quality Assurance Specialist you will:
Responsible for the development, coordination, and implementation of the Quality Management Plan (QMP) for the Strategic National Stockpile.
Ensure that the plan and associated guidelines and established procedures are consistent with federal regulation and the provisions of the Food and Drug Administration's current Good Manufacturing Practice (cGMP) standards.
Serve as the subject matter expert in development of Quality Management Systems (QMS) that support quality assurance efforts.
Develop operating criteria and procedures, staff and operational standards and protocols.
Review quality assurance audit findings, identifies compliance and deficiency issues that are critical or resistant to control, assesses programmatic impact and develops alternative methods or approaches for inclusion in the QMP.
Coordinate the resolution of issues related to the QMS components, including planning, implementation, and evaluation of process improvement tools utilized.
Serve as a senior expert and advisor to management for quality assurance program management issues affecting the national stockpile.
Participates actively in planning efforts to improve organizational reliability and responsiveness.
Provide technical advice to other agencies and organizations and serves on interagency boards, special committees or task groups concerned with quality assurance issues.
Conduct audits of SNS facilities and contract partner operations to document compliance with program requirements, identify deficiencies, and ensure that corrective and preventive actions and maintenance goals are being met.
Plan work to be accomplished by subordinates, sets and adjust short-term priorities, prepares schedules for completion of work, when necessary.
Assign work to subordinates based priorities, considering difficulty and requirements of assignments as well as the capabilities of employees.
Gives advice, counsel, or instruction to employees on both work and administrative matters.
Convenes interview panels for candidates for positions in the work unit.
Recommends appointment, promotion or reassignment of employees to supervisor.
Hears and resolves complaints from employees, referring group grievances and more serious unresolved complaints to a higher-level supervisor.
Help Requirements Conditions of Employment US Citizenship is required.
Background Investigation may be required.
One-year probationary period may be required.
Travel, transportation, and moving expenses will be paid:
No Bargaining Unit Position:
No Drug Screening Required:
No Promotion potential:
No Supervisory position:
Yes:
This position has 20% supervisory duties, candidates must also have demonstrated or shown the potential to develop the necessary knowledge, skills, and abilities.
Applicants should describe any previous experience or responsibilities which could be used in relation to the supervisory requirements of this position.
Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
All qualification requirements must be met by the closing date of the announcement.
Public Trust/Moderate Background Investigation (5) is required.
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 Federal government, as the largest employer in the Nation, can and should show the way towards achieving drug-free workplaces through programs designed to offer drug users a helping hand, and at the same time demonstrating to drug users and potential drug users that drugs will not be tolerated in the 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.
Applicants tentatively selected for this position may be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to reasonable suspicion and post-accident drug testing upon hiring.
If required to submit to urinalysis, the appointment to the position will be contingent upon a negative applicant drug test result.
In order to demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.
Qualifications Minimum
Qualifications:
Applicants must have one year of specialized experience at or equivalent to the GS-13 grade level of in the Federal service as defined in the next paragraph.
Specialized experience is experience which is directly related to the position which has equipped the applicant with the particular knowledge, skills and abilities (KSAs) to successfully perform the duties of the position to include experience providing guidance and advisory services to management and program staff on policies, processes, and procedures related to working in public health emergency preparedness programs at the federal, state, tribal, local, or territorial level.
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.
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, knowledge, and skills 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 job does not have an education qualification requirement.
Additional information Additional selections may be made within the same geographical location CDC-wide.
Males born after December 31, 1959 must be registered or exempt from Selective Service (see http:
//www.
sss.
gov).
To view the questionnaire, click on the following link:
https:
//apply.
usastaffing.
gov/ViewQuestionnaire/11998581 If you are unable to apply online, please contact the CDC Helpdesk by phone (770) 488-1725 or email HRCS@CDC.
GOV.
Applicants are strongly encouraged to apply online.
Applying online, through your USAJOBS account, will expedite the application process and allow you to check your application.
If you utilize the Alternate Application method, your USAJOBS account will not display this application or status updates related to this application.
Positions may be available in multiple locations across the United States, or eligible for telework and remote work opportunities, based on the Center for Disease Control and Prevention's (CDC's) Workplace Flexibilities Policy.
To Remain An Active Duty USPHS Commissioned Corps OfficerJoin more than 6,500 highly qualified public health professionals as part of the U.
S.
Public Health Service.
Overseen by the Surgeon General, you will be part of an elite and diverse team of professionals essential to public health leadership and exemplary clinical service.
PHS Officers interested in performing the duties of this position with the Commissioned Corps, you are welcome to apply and receive a courtesy referral.
Note that a courtesy referral is not a competitive civil service process and does not provide civil service status for the selected employee.
Click Herefor the comparison chart of Commissioned Corps ranks to civil service, which advises you on potential billet rankings.
Job Type:
Full-time Pay:
$122,907.
00 - $159,776.
00 per year Schedule:
8 hour shift Day shift Monday to Friday Work setting:
In-person Ability to commute/relocate:
Atlanta, GA:
Reliably commute or planning to relocate before starting work (Required) Shift availability:
Day Shift (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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