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DatePosted

6/5/2023 1:12:43 PM

FirstLocation

Atlanta, Georgia

33.7483

Location

Atlanta, Georgia

Department

Department of Health and Human Services

Agenc

Centers for Disease Control and Prevention

SubAgenc

National Center for Immunization and Respiratory Diseases (NCIRD)

MajorDuties

As a Quality Assurance Specialist, you will: Serve as a project lead within the Regulatory Affairs Activity (RAA) and will be responsible for the planning, development, delivery and implementation of regulatory affairs programs to address compliance needs, including training programs, policy, guidance and tools. Participate in interagency regulatory and emergency response coordination efforts. Lead projects to develop policies, training and/or tools to support compliance with Federal and Drug Administration (FDA) laws, regulations and guidance for NCIRD and CDC medical device development, manufacture, use and distribution activities. Ensure that all RAA documents are controlled by an NCIRD and CDC quality system-compliant document control program.

Education

Requirements

US Citizenship is required. Background Investigation is required. E-Verify: 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. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing. All qualification requirements must be met by the closing date of the announcement. One-year probationary period may be required. Travel, transportation, and moving expenses may be paid: No Drug Screening Required: No Annual Leave for non-federal service may be authorized. No Promotion potential: No Supervisory position: No Public Trust/Moderate Background Investigation (5) is required Current or Former Political Appointees: Agencies must seek prior approval from the Office of Personnel Management (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. Failure to disclose this information could result in disciplinary action including removal from Federal Service. Current or Former Political Appointees: Submit SF-50.

Evaluations

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 to which your background matches the competencies required for this position. Qualified candidates will be ranked into one of three categories: Best Qualified, Well Qualified or Qualified. 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). Knowledge of laboratory test design and validation processes and assessment of laboratory capacity Knowledge of U.S. laws and regulations related to development and performance of laboratory tests, Quality Management System (QMS) guidance, and CDC directives, policies and practices. Skill in communication and public relations techniques to represent the Agency at conferences and meetings concerning program objectives and policies, special problems and issues.

HowToAppl

This vacancy is also being announced concurrently with vacancy announcement HHS-CDC-MP-23-11987579 under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered. Current, active duty PHS Officers interested in performing the duties of this position within the Commissioned Corps (not as a career/career-conditional employee) are encouraged to apply under the merit promotion announcement (if applicable). To apply for this position, you must complete the online application and submit the documentation specified in the Required Documents section. A complete application package must be submitted by 11:59 PM (EST) on06/12/2023 of this announcement to receive consideration. To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply. If you do not have a USAJOBS account, you will need to create one before beginning the application. Follow the prompts to select your r�sum� and/or other supporting documents to be included with your application package. You will have the opportunity to upload additional documents to include in your application before it is submitted. Your uploaded documents may take several hours to clear the virus scan process. After acknowledging you have reviewed your application package, complete the Include Personal Information section as you deem appropriate and click to continue with the application process. You will be taken to the online application which you must complete in order to apply for the position. Complete the online application, verify the required documentation is included with your application package, and submit the application. To verify the status of your application, log into your USAJOBS account (https://my.usajobs.gov/Account/Login), all of your applications will appear on the Welcome screen. The Application Status will appear along with the date your application was last updated. For information on what each Application Status means, visit: https://www.usajobs.gov/Help/how-to/application/status/. If you cannot apply online: If you are unable to apply online, please contact the CDC Helpdesk by phone (770) 488-1725 or email [email protected]. 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. 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. To view the questionnaire, click on the following link: https://apply.usastaffing.gov/ViewQuestionnaire/11987580

WhatToExpectNext

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement. You will receive notice via email once this process is completed (generally 4-6 weeks). Your position may be eligible for workplace flexibilities which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested once you have become an employee, in accordance with the CDC Workplace Flexibilities policy. HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

RequiredDocuments

To apply for this position, you must submit a complete Application Package which includes: 1. R�sum� - Your r�sum� showing name, work schedule, hours worked per week, dates (month/year) of employment and duties performed. (If you are a current or former Federal employee provide your pay plan, series and grade in your resume, i.e., GS-0301-9). Do not include the following types of information in your profile or resume: Classified or government sensitive information Social Security Number (SSN) Photos of yourself Personal information, such as age, gender, religious affiliation, etc. Encrypted and digitally signed documents 2. Veterans' Preference (If Applicable) - If claiming veterans' preference, you must submit a copy of your DD-214 (Member 4 copy), or other official documentation from a branch of the Armed Forces or the Department of Veterans Affairs showing dates of service and type of discharge. Ten-point preference eligibles must also submit an Application for 10-point Veteran Preference, SF-15, along with the required documentation listed on the back of the SF-15 form. For more information on veterans' preference view FedsHireVets 3. Other supporting documents: Cover Letter, optional Career Transition Assistance Program documentation, if applicable (e.g., Certification of Expected Separation, Reduction-In-Force Separation Notice, or Notice of Proposed Removal; SF-50 that documents the RIF separation action; and most recent performance appraisal). Failure to submit any of the above-mentioned required documents will result in loss of consideration due to an incomplete application package. It is your responsibility to ensure all required documents have been submitted. For R�sum� and Application Tips visit: https://help.usajobs.gov/index.php/Tips.

Benefits

OtherInformation

This position is eligible for inclusion in the Bargaining Unit. If the duty station is finalized in Atlanta, Georgia, employees in this position will be represented by the American Federation of Government Employees, AFGE Local 2883, (BU Code - 1872) or National Alliance of Postal and Federal Employees, NAPFE Local 303, (BU Code: 1868). Additional selections may be made within the same geographical location CDC-wide. The utilization of shared certificates within multiple Centers of the Center of Disease Control and Prevention may be used from this vacancy announcement for specialties to include but not limited to: Applied Epidemiology, Behavioral Epidemiology, Chronic Diseases, Emergency Preparedness and Response, Emerging Infectious Diseases, Environmental Health, HIV/AIDS, Immunization, Infectious Diseases (e.g. Viral, Parasitic, etc.), Influenza, Malaria, Non-communicable Diseases, Outbreak Investigations, Sexually Transmitted Diseases (STDs), Surveillance, Tropical Medicine, Tuberculosis (TB), Viral Hepatitis, and/or Zoonotic Diseases. Recruitment and/or relocation incentives may be authorized. Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov). For information on "People with Disabilities" please see http://opm.gov/disability/PeopleWithDisabilities.asp and https://www.opm.gov/policy-data-oversight/disability-employment/getting-a-job/sampleschedaletters.pdf. Former and present Peace Corps personnel may be considered to fill vacancies. Peace Corps personnel are eligible for consideration if you have completed at least 36 months of continuous service, without a break in service of 3 days or more. This requirement is consistent with section 7(a) of the Peace Corps Act (22 U.S.C. 2506), which pertains to the appointment of Peace Corps staff (not volunteers) and is applicable within 3 years after separation from qualifying service with the Peace Corps. A copy of your SF-50 is required to support your request. Peace Corps Volunteers may be considered to fill vacancies. Executive Order 11103 provides eligibility for appointment in the competitive service for any person who is certified by the Director of the Peace Corps as having served satisfactorily as a Volunteer or Volunteer Leader under the Peace Corps Act and who passes such examination as the Office of Personnel Management may prescribe.

KeyRequirements

WithinArea

False

CommuteDistance

0

ServiceType

01

AnnouncementClosingType

01

SecurityClearance

Other

DrugTestRequired

False

AdjudicationType

Credentialing,Suitability/Fitness

PositionSensitiviti

Moderate Risk (MR)

HiringPaths

FED-TRANSITION, PUBLIC, VET

JobAnnouncementNumber

HHS-CDC-DE-23-11987580

SalaryRange

$104008.0 to $135209.0/PA

MinimumRange

MaximumRange

OpenPeriod

6/5/2023 1:12:43 PM to 6/12/2023 11:59:59 PM

ScheduleType

Full-Time

AgencyMarketingStatement

The Centers for Disease Control and Prevention (CDC), a major operating component of the Department of Health and Human Services, is the nation's leading science-based, data-driven, service organization that protects the public's health. For more than 75 years, we have put science into action to help children stay healthy so they can grow and learn; to help families, businesses, and communities fight disease and stay strong; and to protect the public's health. In addition, CDC also has a critical preparedness and response mission: we protect the American people from health threats, research emerging diseases, and mobilize public health programs with domestic and international partners. CDC's 24/7 Emergency Operations Center (EOC) unites highly trained experts, well established processes, and state-of-the-art technology to coordinate resources and information as CDC responds to emergencies worldwide. Every CDC employee has a role in supporting public health emergency management, whether through temporary assignments to emergency responses or sustaining other CDC programs and activities while colleagues respond. CDC offers exciting and dynamic opportunities in Public Health with global impact. Examine how you can use your talent, training, and passion to help CDC continue as the world's premier public health organization. Please visit www.cdc.gov for more information.

JobSummar

As a global leader in public health & health promotion, CDC is the agency Americans trust with their lives. In addition to our everyday work, each CDC employee has a role in supporting public health emergency management, whether through temporary assignments to emergency responses or sustaining other CDC programs and activities while colleagues respond. Join our team to use your talent, training, & passion to help CDC continue as the world's premier public health organization. Visit www.cdc.gov

QualificationsRequired

Requirements (continued): 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. Minimum Qualifications: Applicants must have at least one year of specialized experience at or equivalent to the GS-12 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 in leading and coordinating regulatory affairs projects and ensuring compliance of FDA-regulated products and services. 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.

AgencyContactInfo

CDC HELPDESK 1600 Clifton Road NE Atlanta GA US 30333

Telephone

(770) 488-1725

Email

JobCategor

Quality Assurance

SeriesAndGrade

1910- GS-13/13

IsPositionLocationForeign

0

PositionsCount

1

Placeholder1

1105

Placeholder2

Career transition (CTAP, ICTAP, RPL), The public, Veterans

score

1.0