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Laboratory Quality Control Specialist

Centers for Disease Control and Prevention

Fort Collins, COFull-time$83–108K/yrPosted today

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At a glance

Compensation
$83–108K/yr
Location
Fort Collins, CO
Schedule
Full-time
Work Authorization
Not specified

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Job overview

The Laboratory Quality Control Specialist coordinates biological specimen shipments and conducts laboratory quality reviews, workspace inspections, and audit liaison work. The role evaluates compliance with quality-management systems, clinical laboratory practices, regulations, and national and international standards. Candidates qualify through specified education, specialized experience, or a combination of graduate education and experience, including microbiology experiment and protocol management.

Skills & qualifications

RequiredNice to have

Skills

Biological Specimen ShippingLaboratory Quality ReviewsInternal AuditsLaboratory Standards ComplianceMicrobiology ExperimentsNext-Generation SequencingExperiment Protocol Management

Qualifications

Biological Sciences or RelatedOne Year Specialized ExperiencePhD or Equivalent Doctoral DegreeThree Years Graduate EducationGraduate Education and Experience Combination

Full job description

Summary

This position is located in the Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, headquartered in Atlanta, Georgia.

Duties

WHAT YOU'LL BE DOING DAY TO DAY As a Laboratory Quality Control Specialist, you will: Coordinate shipments of biological specimens, including special and hazardous items, ensuring proper packaging and compliance with local, state, and Federal laws, regulations, and CDC biological-shipping guidelines. Conduct continuous laboratory quality reviews to determine compliance with quality-management systems, clinical laboratory practices, regulatory requirements, and national/international standards, including Clinical Laboratory Improvement Amendments (CLIA), Clinical and Laboratory Standards Institute (CLSI), and Food and Drug Administration (FDA) requirements. Regularly and routinely inspect and review assigned laboratory workspaces to identify and correct unsafe conditions and ensure compliance with applicable federal and state safety and health regulations and established laboratory safety policies. Serve as the laboratory's primary liaison for audits, review committees, and third-party inquiries Qualifications

WHAT WE ARE LOOKING FOR Basic Qualifications: A. Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. OR B. Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education. AND Minimum Qualifications: You must have one year of specialized experience to perform successfully the duties of the position. To be creditable, specialized experience must have been equivalent to at least the GS-09 grade level in the Federal service performing ALL of the following: coordinating and routing complex shipments of biological, hazardous, and temperature-sensitive specimens in compliance with transportation laws; conducting quality reviews and internal audits to ensure compliance with laboratory standards and regulations (such as CLIA, CLSI, or FDA); serving as a primary liaison for laboratory audits and external quality assessments; and Independently planning and managing microbiology experiments and protocols (such as next-generation sequencing). OR Applicant must have a Ph.D. or 3 years of progressively higher-level graduate education leading to a Ph.D. degree or equivalent doctoral degree in an appropriate field. OR Applicant must have a combination of graduate level education and specialized experience which meets 100% of the qualification requirements for the position. Documenting experience: IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. Do not copy and paste the duties, specialized experience, or occupational application questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. 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; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited. OPM Qualification General Policies Website

Education

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov. How You Will Be Evaluated

You will be evaluated based on how well you meet the qualifications listed in this announcement. Evaluation will be based on your application materials (such as your resume and supporting documents), your responses to the application questionnaire, and the results of all required assessments. Resume Requirement Your resume must not exceed two (2) pages in length. Basic Qualification Question As part of the application process, you must answer a question addressing whether you meet the Basic Requirement for this position, as described in this announcement. Minimum Qualification Question As part of the application process, you must answer a minimum qualification question addressing whether you meet the Specialized Experience required for this position, as described in this announcement. Your response must be supported by the experience documented in your resume. If your resume does not demonstrate the required Specialized Experience, you may be found not qualified. Assessment Process USA Hire Assessment You are required to complete a USA Hire assessment for this position. HR Resume Review Human Resource (HR) Specialists will review your resume to determine whether you meet the required Specialized Experience. Applicants who successfully pass all of the assessment(s) may be referred to the Hiring Manager for consideration. You must complete all required steps in the process, including submitting an application and resume and participating in the assessments, to be considered for this position. Note: This vacancy 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. Please click here for more information on OPM's Authorization of Direct Hire authority" Traditional rating and ranking of applications does not apply to this vacancy. Applications will be evaluated against the basic qualifications. Qualified candidates will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines. Veteran's Preference does not apply to the direct hire recruitment procedures. Selections made under this announcement will be processed as new appointments to the civil service. Current civil service employees would, therefore, be given new appointments to the civil service. To preview the application questionnaire, click the following link: https://apply.usastaffing.gov/ViewQuestionnaire/13058500 Other Information

THINGS YOU NEED TO KNOW Incentives may be authorized; however, this is contingent upon multiple factors, including funds availability. If authorized, certain incentives may require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives may include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. Bargaining Unit Position: No Research position: No Drug Screening Required: Yes Career Transition Assistance Program/Interagency Career Transition Assistance Program (CTAP/ICTAP): For information on how to apply as an CTAP/ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap. To be considered well-qualified under I/CTAP, you must be rated eligible based on minimum qualifications for this position and submit the supporting documents listed under the required documents section of this job announcement. Reemployment Priority List (RPL): To receive selection priority for this position, individuals on the RPL must meet the qualification requirements, complete all required assessments and be rated as qualified. RPL candidates are ranked using Category Rating procedures Beginning January 1, 2010, agencies must seek prior approval from 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. Resumes must not exceed two (2) pages in length. Application requirements are clearly stated in this Job Opportunity Announcement. Failure to submit a resume and any other required documentation identified in this announcement will result in removal from further consideration. 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 any interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS. 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 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.

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