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Clinical Laboratory Scientist (Quality Assurance)

Company

US National Institutes of Health

Address , , Md
Employment type FULL_TIME
Salary $112,015 - $145,617 a year
Expires 2023-06-10
Posted at 1 year ago
Job Description

Duties

As a GS-0644-13 Clinical Laboratory Scientist (Quality Assurance), your duties may include, but are not limited to the following:

  • Provides guidance to patient-care physicians on specimen collection and handling techniques, and the interpretation and limitations of test procedures.
  • Plans, directs, and coordinates the Department's comprehensive quality assurance program in accordance with the requirements of regulatory and accrediting organizations; the policies, practices and procedures of DHHS, NIH, Clinical Center and OLM; and state of the art practices in laboratory medicine, medical research, patient care and medical training.
  • Develops and implements departmental quality management standard operating procedures (SOPs), policies and instructions including the Department's Quality Assurance Plan, improvement and corrective action plans, inspection and assessment protocols, records management plans and computer systems validation.
  • Conducts evaluations and studies of department operations to ensure compliance with regulatory requirements of accrediting organizations, Health and Human Services, National Institue of Health and Clinical Center policies, procedures and practices and state of the art practices in patient care and laboratory quality management.
  • Presents training sessions on quality management of clinical laboratories, technical information and management theory, and conducts discussion sessions for first line and senior supervisors on a variety of quality management issues.

Requirements

Conditions of Employment

  • Males born after December 31, 1959 must be registered with the Selective Service.
  • This position is designated as Tier 1 Emergency Essential (See Additional Information).
  • If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
  • At the supervisor's discretion, this position may offer work schedule flexibilities such as telework and alternative work schedules.
  • Position requires Education, please provide transcripts.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.

Qualifications

You qualify at the GS-13 level, if you meet the following qualification requirements:

Basic Requirements Education:
A Bachelor's or graduate/higher level degree from a regionally accredited college/university including courses in biological science, chemistry and mathematics, AND successful completion of a Medical Laboratory Scientist/Clinical Laboratory Scientist program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
OR
A full 4-year course of study that included 12 months in a college or hospital-based medical technology program or medical technology school approved by a recognized accrediting organization. The professional medical technology curriculum may have consisted of a 1-year post- bachelor's certificate program or the last 1 or 2 years of a 4-year program of study culminating in a bachelor's in medical technology.
OR
A Bachelor's or graduate/higher level degree from an accredited college/university, including 16 semester hours (24 quarter hours) of biological science (with one semester in microbiology), 16 semester hours (24 quarter hours) of chemistry (with one semester in organic or biochemistry), one semester (one quarter) of mathematics, AND five years of full time acceptable clinical laboratory experience in Blood Banking, Chemistry, Hematology, microbiology, Immunology and Urinalysis/Body Fluids. This combination of education and experience must have provided knowledge of the theories, principles, and practices of medical technology equivalent to that provided by the full 4-year course of study described in A or B above. All science and mathematics courses must have been acceptable for credit toward meeting the requirements for a science major at an accredited college or university. Acceptable experience is responsible professional or technician experience in a hospital laboratory, health agency, industrial medical laboratory, or pharmaceutical house; or teaching, test development, or medical research program experience that provided an understanding of the methods and techniques applied in performing professional clinical laboratory work. Certification/licensure as a medical technologist (generalist) obtained through written examination by a nationally recognized credentialing agency or State licensing body is a good indication that the quality of experience is acceptable.
ADDITIONAL REQUIREMENT:
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector performing the following tasks: providing quality assurance program management for a clinical research laboratory; developing new approaches to measure the effectiveness and efficiency of a clinical research facility; developing corrective action plans to address accreditation and regulatory compliance issues for a clinical research laboratory; and developing standard operating procedures, policies and procedures to ensure quality assurance of the operations of a clinical research laboratory.
Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.
Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11892720

Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Additional information

  • NIH may repay certain outstanding Federally insured student loans to facilitate the recruitment and retention of highly qualified people. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
  • Visit our Applicant FAQs page for helpful information on the application process.
  • Must be able to perform the essential duties of the position, with or without reasonable accommodation.
  • We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.
  • Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.
  • This position is designated as an "emergency essential" position and the selected candidate will be considered an "emergency essential" employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage.
  • A one-year probationary period may be required upon selection/placement.
  • PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration
  • The NIH maintains a tobacco free work environment and campus.
  • A one-year probationary period may be required upon selection/placement.
  • The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

  • Benefits Review our benefits

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):

  • 2. Ability to conduct evaluations and studies of laboratory operations in a clinical research facility.
  • 1. Ability to plan, direct and coordinate a quality assurance program for a laboratory in a clinical research facility.
  • 4. Knowledge of laboratory testing procedures and principles of medical technology in a clinical research facility.
  • 3. Skill in developing and providing guidance to ensure quality assurance in a major laboratory in a clinical research facility.

If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:
  • Best Qualified - for those who are superior in the evaluation criteria
  • Qualified - for those who only meet the minimum qualification requirements
  • Well Qualified - for those who excel in the evaluation criteria
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. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.
To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings by the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.
To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.

  • Job title
  • 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.

    REQUIRED FOR ALL APPLICANTS
    RESUME:
    Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.
    To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

    • Job title
    • Name of employer
    • Beginning and ending dates of employment (month/day/year format)
    • Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
    • Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
    • Series and grade or equivalent (if a federal position)

    If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.
    Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.
    For resume writing guidance, please visit the following resources: NIH Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.
    ASSESSMENT QUESTIONNAIRE:
    You must submit a completed assessment questionnaire.
    Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.
    REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
    To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.
    • Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
    • Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
    • Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
    • Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.

    The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.
    If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.
    Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

    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.

  • Series and grade or equivalent (if a federal position)
  • Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.
  • Benefits Review our benefits
  • Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
  • Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.
  • Equal Employment Opportunity (EEO) Policy
  • Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
  • To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
  • Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
  • Reasonable accommodation policy
  • Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
  • Beginning and ending dates of employment (month/day/year format)
  • How to Apply

    To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 04/14/2023 to receive consideration.

    • To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
    • Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.
    • Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
    • Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11892720
    • Verify all required documentation is included in your application package, review your responses to the assessment questionnaire for accuracy, and then submit your application.
    In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.
    We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at [email protected].
    If you need any other accommodation or assistance with applying, please contact Paula Landry at [email protected]. Requests for reasonable accommodations must be made before the announcement closing date.
    NIH's EEO and Diversity and Inclusion Policy Statement
    Visit the NIH's Office of Equity, Diversity, and Inclusion site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.

    Agency contact information

    Paula Landry

    Phone

    301-402-7903

    Email

    [email protected]

    Address

    National Institutes of Health
    6701 Rockledge Dr
    Bethesda, MD 20892
    US

    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.
    Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.
    At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.

  • Signature and false statements
  • Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11892720
  • Privacy Act
  • Social security number request
  • New employee probationary period
  • Verify all required documentation is included in your application package, review your responses to the assessment questionnaire for accuracy, and then submit your application.
  • Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
  • Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
  • Financial suitability
  • Name of employer
  • Selective Service
  • Fair and Transparent

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

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

Required Documents

REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.
To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

  • Job title
  • Name of employer
  • Beginning and ending dates of employment (month/day/year format)
  • Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
  • Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
  • Series and grade or equivalent (if a federal position)

If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.
Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.
For resume writing guidance, please visit the following resources: NIH Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.
ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.
Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.
REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.
  • Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
  • Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
  • Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.
  • Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.

The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.
If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.
Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

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.


Help

This job is open to

  • Military spouses
  • The public U.S. Citizens, Nationals or those who owe allegiance to the U.S.

Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.