Public Notice for Direct Hire (STEM) - Laboratory Quality Management Specialist

This role is with Centers for Disease Control and Prevention. WayUp is partnering with Centers for Disease Control and Prevention to hire top talent.

Duties

The CDC utilizes Direct/Expedited Hire Authorities to fill vacancies in a variety of occupations. This vacancy is a REPOSITORY of applications. Duties and responsibilities vary and may increase according to the grade level of the position. Applications may be periodically referred to hiring managers both during the open period and after the closing date. Because of the large number of applications anticipated, applicants' status will not be updated.

This public notice will be used to fill the positions listed below at multiple grade levels and locations.

• Laboratory Quality Management Specialist Grades GS-11 through GS-14 Applicant Expiration: Applications will expire 4 months after submission/resubmission. To remain eligible for consideration, reapplying is required.
  
  

Duties may include but are not limited to:

• Assure implementation and maintenance of quality management system/essentials program and plan; and adherence to applicable guidelines and regulations, such as Clinical Laboratory Improvement Amendments (CLIA), Clinical and Laboratory Standards Institute (CLSI), Food and Drug Administration (FDA), and other national and international standards/accreditations.
• Ensure laboratory quality management requirements such as, standard operating procedures and protocols are in place, maintained, and meet appropriate regulatory requirements.
• Conduct periodic internal and external quality audits to include assessment of laboratory data, documenting regulatory compliance and identifying/reporting deficiencies.
• Advise management regarding nonconformities; recommend appropriate investigative, remedial and corrective action.
• Comply with all applicable federal and state safety and health regulations and established agency/organizational safety policies.
• Maintain required certifications and professional expertise in a science field/research quality control or assurance clinical laboratory standards, guidelines, and regulations.
  
  

Requirements

Conditions of Employment

Due to the Centers for Disease Control and Prevention's (CDC's) process enhancement to use Shared Certificates throughout the Agency, some of the requirements below may differ:

• US Citizenship is required.
• Males born after December 31, 1959 must be registered or exempt from Selective Service ( http://www.sss.gov ).
• May be subject to a Background/Security Investigation. Security clearance level may differ from the position announced when certificates are shared .
• CDC participates in the USCIS Electronic Employment Eligibility Verification Program ( E-Verify ). If selected, CDC will determine your employment eligibility using your social security number.
• Direct deposit is required.
• One-year probationary period may be required.
• This position may be subject to a Collective Bargaining Agreement.
• This public notice may be used to fill managerial positions with 20% supervisory duties. Applicants should describe any previous experience or responsibilities which could be used in relation to supervisory duties that demonstrate or show the potential to develop the necessary knowledge, skills, and abilities.
• Positions may be filled as permanent or term appointments.
• This position may be subject to the OGE Financial Disclosure requirements of the Ethics in Government Act of 1978 (P.L. 95-521). CDC inspires public confidence in its trust responsibilities and mission by maintaining high ethical principles. If selected, you may be required to complete a Confidential Financial Disclosure Report (OGE Form 450) to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. If identified, this will be an annual requirement.
• In accordance with Executive Order 12564 of September 15, 1986, The Department of Health and Human Services (HHS) is A Drug-Free Federal Workplace. This position may require a Drug Test and be subject to Random Drug Testing. The position may require the submission of a 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 test result.
  
  

Qualifications

• Basic Qualifications: * Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
  
  

or

• Combination of education and experience: Courses equivalent to a major, as shown above, plus appropriate experience or additional education.
  
  

Minimum Qualifications:

To qualify at the GS-11 grade level, you must have at least one year of specialized experience at or equivalent to the GS-09 grade level, which must include the following experience: performing quality reviews and measurement of laboratory functions involved in environmental response, biological testing of human and animal specimens, and pharmacology or other related science research applications or activities.

• OR have completed 3 years of progressively higher level graduate education leading to a Ph.D degree or Ph.D. or equivalent doctoral degree in a field which demonstrates the knowledge, skills, and abilities necessary to perform the work of the position, such as biological sciences, agriculture, natural resource management, chemistry or related disciplines appropriate to the position.
• OR have a combination of education and specialized experience that together meets 100% of the qualification requirement for this position.
  
  

To qualify at the GS-12 grade level, you must have at least one year of specialized experience at or equivalent to the GS-11 grade level, which must include the following experience: conducting clinical laboratory quality reviews to ensure compliance with clinical laboratory quality management systems, regulatory guidelines, policies, standards, processes and practices.

To qualify at the GS-13 grade level, you must have at least one year of specialized experience at or equivalent to the GS-12 grade level, which must include the following experience: performing laboratory quality management reviews; planning, developing and implementing laboratory quality control standards and practices; and making recommendations for compliance in reporting findings.

To qualify at the GS-14 grade level, you must have at least one year of specialized experience at or equivalent to the GS-13 grade level, which must include the following experience: in the development of and enhancement of Clinical Laboratory Improvement Amendments (CLIA) compliant laboratory testing systems; validating tests to meet CLIA requirements; and in the implementation of laboratory quality management systems in research and non-research laboratories.

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.

Promotion potential: Promotion to the next grade level is at management's discretion and is based on your meeting qualifications and time-in-grade requirements, demonstrated ability to perform the higher-level duties, the continuing need for the higher-level duties, and administrative approval. Promotion to the next grade level is not guaranteed and no promise of promotion is implied.

Education

A copy of your transcripts or equivalent documentation is required for positions with an education requirement, or if you are qualifying based on education or a combination of education and experience. An official transcript will be required if you are selected.

A college or university degree generally must be from an accredited (or pre-accredited) college or university recognized by the U.S. Department of Education. For a list of schools which meet these criteria, please refer to Department of Education Accreditation page .

• FOREIGN EDUCATION: Education completed in foreign colleges or universities may be used to meet the requirements. You must show proof the education credentials have been deemed to be at least equivalent to that gained in conventional U.S. education program. It is your responsibility to provide such evidence when applying. For more information, visit https://sites.ed.gov/international/recognition-of-foreign-qualifications/ .
  
  

Additional information

• Telework: This position has been designated as telework eligible and:
• May include telework options and/or flexible work scheduling. These options may be requested once you have become an employee and you will be required to sign a Workplace Flexibilities Agreement that details remote or telework working conditions and expectations in accordance with the HHS Workplace Flexibilities Policy .
• May be eligible for inclusion in the Bargaining Unit.The name of the union, local, and BU Codes will be provided upon selection.
• For more information visit: https://www.usajobs.gov/Help/faq/job-announcement/telework/
  
  

May be required to work other than normal duty hours, to include evenings, weekends and/or holidays.

Applicant Expiration: Applications will expire 4 months after submission/resubmission. To remain eligible for consideration, reapplying is required.

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 if declared a drug-testing position. 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.

Incentives:

• Recruitment and/or relocation incentives may be authorized.
• Annual Leave for non-federal service may be authorized.
• Student loan repayment incentive may be authorized.
• Travel, transportation, and moving expenses may be paid.
• PCS Expenses may be authorized, subject to the terms of the Joint Travel Regulation (JTR). Benefits
  
  

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 window Learn more about federal benefits .

Review our 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.
  
  

The utilization of shared certificates for additional selections within the same geographical area can be made from multiple Centers of the Center of Disease Control and Prevention (CDC) and Agency for Toxic Substance and Disease Registry (ATSDR).

• This position is being filled through Direct Hire Authority for this occupation and is open to all US Citizens. Vacancies will be filled through OPM's Direct Hire Authority. Veterans' preference and traditional rating and ranking of applicants do not apply to positions filled under this announcement. All applicants who meet the minimum qualification requirements will be forwarded to the selecting official for consideration. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority.
  
  

For more information on OPM's authorization of Direct Hire Authority, please visit: https://www.opm.gov/policy-data-oversight/hiring-information/direct-hire-authority/

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.

Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP): CTAP/ICTAP eligibles must meet all of the requirements outlined in the qualification section of this announcement in order to be considered "well qualified."

Required Documents

As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.

To apply for this position, you MUST submit a complete Application Package which includes the following. Note: All documents must be in English.

• 1\. Resume \- Must reflect name, work schedule, hours worked per week, dates (month/year) of employment and duties performed.
• Current/former Federal employee:
• Must reflect pay plan, series and grade, i.e., GS-0301-9. Dos and Don'ts: -
  
  

www.usajobs.gov/Help/faq/application/documents/resume/what-to-include/

www.usajobs.gov/Help/faq/application/documents/resume/what-to-leave-out/

Cover Letter is optional.

• 2. Transcripts (if applicable) \- You may submit an unofficial transcript. An official transcript from an accredited educational institution is required if you are selected.
• 3\. Career Transition Assistance Plan (CTAP)/ Interagency Career Transition Assistance Plan (ICTAP):
• Supporting documentation i.e., Reduction in Force (RIF) notice or Certificate of Expected Separation (CES), AND most recent:
• Current annual performance appraisal
• SF-50 (Notification of Personnel Action) 4\. 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.
  
  

Failure to submit any of the above-mentioned required documents may result in loss of consideration due to an incomplete application package. It is your responsibility to ensure all required documents have been submitted.

For Résumé and Application Tips visit: https://help.usajobs.gov/index.php/Tips.

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.

How to Apply

This is an OPEN CONTINUOUS ANNOUNCEMENT and will remain open until 01/30/2025.

To apply for this position, you must complete the online application and submit the documentation specified in the Required Documents section.

Applicant Expiration: Applications will expire 4 months after submission/resubmission. To remain eligible for consideration, reapplying is required.

A complete application package must be submitted by 11:59 PM (EST) on the closing date, 01/30/2025, 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 résumé 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 are unable to apply online: -

• Applicants external to CDC \- Contact the CDC Helpdesk by phone (770) 488-1725 or email HRCS@CDC.GOV . -
• Applicants internal to CDC \- Contact the OHR Service Desk . 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.
  
  

To view the questionnaire, click on the following link:

https://apply.usastaffing.gov/ViewQuestionnaire/12477716

Agency contact information

CDC HELPDESK

Phone (770) 488-1725 Email HRCS@CDC.GOV

Address NCIRD-DIVISION OF VIRAL DISEASES-OFFICE OF THE DIRECTOR

1600 CLIFTON RD NE

ATLANTA, GA 30333

US

Learn more about this agency

Next steps

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.

Fair and Transparent

The Federal hiring process is set up to be fair and transparent. Please read the following guidance.

• Criminal history inquiries
• Equal Employment Opportunity (EEO) Policy
• Financial suitability
• New employee probationary period
• Privacy Act
• Reasonable accommodation policy
• Selective Service
• Signature and false statements
• Social security number request