Public Notice for Direct Hire (STEM) - Laboratory Quality Management Specialist at U.S. Department of Health and Human Services (HHS Careers) in Houston, TX

Summary

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

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 ().
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 (). 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.

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:

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

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:

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:

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 .

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.