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Public Notice For Direct Hire (Stem) - Laboratory Quality Management Specialist

Centers for Disease Control and Prevention | Philadelphia, PA

Posted Date 7/25/2024
Description 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 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.
Basic Qualifications:

  1. Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.

    or

  2. 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.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/.

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