Clinical Laboratory Scientist (Quality)

Summary

The incumbent works with the Quality Management Officer to develop policies and guidance and conduct evaluations to ensure the highest level of quality testing within the department's services to optimize the safety of employees and patients within the department and the Clinical Center; and to ensure the department operates in compliance with the policies, procedures and practices required by the Clinical Center, NIH, DHHS and all regulatory and accreditation organizations.

This job is open to

• Career transition (CTAP, ICTAP, RPL)
  
  Federal employees who meet the definition of a "surplus" or "displaced" employee.
• Family of overseas employees
  
  Family members of a federal employee or uniformed service member who is or was, working overseas.
• Federal employees - Competitive service
  
  Current or former competitive service federal employees.
• Individuals with disabilities
• Land & base management
  
  Certain current or former term or temporary federal employees of a land or base management agency.
• Military spouses
• Peace Corps & AmeriCorps Vista
• Special authorities
  
  Individuals eligible under a special authority not listed above, but defined in the federal hiring regulations.
• Veterans

Clarification from the agency

You must be a current or former federal employee eligible to apply under merit promotion procedures or otherwise be eligible as a status applicant (e.g. Veterans Employment Opportunity Act) OR be an individual who is eligible through an OPM interchange agreement or for a non-competitive appointment.

Duties

As a GS-0644-12 Clinical Laboratory Scientist (Quality) your duties may include but are not limited to the following:

• Leading quality improvement processes based on best practices; identifying opportunities for improvement and providing leadership with the initiation and implementation of projects to improve facility processes and meet customer needs.
• Reviewing and identifying compliance gaps for revised FDA cGMP and cGTP guidelines and communications for changes to federal regulations and current guidance for compliance for blood product manufacturing about, but not limited to, blood product manufacturing including donor eligibility and testing for transmissible disease, human cells and tissues donor eligibility determination and testing human cells and tissues for transmissible disease.
• Reviewing External audit findings, following up with any necessary corrective and preventive actions (CAPA) and preparing responses as needed.

Requirements

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Position requires education, transcripts required.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• Tier II Emergency Essential Position.
• If selected, you must pass a pre-employment medical examination.
• The work environment involves potential exposure to infectious agents, such as hepatitis and HIV, when entering Clinical Laboratory areas which are Biohazard Level 2 facilities.

Qualifications

Basic Education Requirements for this position:

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 (external link) 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 QUALIFICATIONS REQUIREMENT:

You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector performing the following tasks: Implementing and monitoring a drug manufacturing Quality System Management Program; drafting quality objectives and quality assurance plans with specific measurable activities and processes; reviewing and identifying compliance gaps for revised FDA cGMP and cGTP guidelines and communications; performing internal quality audits and assisting with the performance of quality audits performed by external reviewers; and developing training programs and conducting training sessions on quality activities and programs for staff members.

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/12515745

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

• This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave.
• 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.
• Veterans' Preference applies only to Schedule A (disability appointment) and Veterans Recruitment Appointments (if applicable).
• 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.
• The NIH maintains a tobacco free work environment and campus.
• Must be able to perform the essential duties of the position, with or without reasonable accommodation.
• Visit our Applicant FAQs page for helpful information on the application process.
• 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.

• 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):

• 1. Ability to implement and monitor a quality management program that promotes process excellence.
• 2. Ability to identify compliance gaps.
• 3. Ability to perform audits and investigations.
• 4. Ability to communicate orally and in writing.

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.

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.

• Benefits
  
  Review our benefits
• 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.
  
  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:
  
  1. Job title
  2. Name of employer
  3. Beginning and ending dates of employment (month/day/year format)
  4. Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
  5. Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
  6. Series and grade or equivalent (if a federal position)
  7. Performance ratings and any monetary or non-monetary awards (optional).
  
  If the position has an education requirement or you are qualifying on the basis of education, you need to 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.
  
  ELIGIBILITY/PREFERENCE DOCUMENTATION:
  
  You must submit the following documentation, if applicable to you AND respond accordingly to the associated question on the online questionnaire. 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.
  
  
  • SF-50 - A copy of your most recent competitive career or career conditional SF-50 that shows the effective date of your latest position and the full performance level. You may obtain a copy of your SF-50 from your human resources office or, if you are an HHS employee, from your eOPF. If you separated from Federal Government employment, you may obtain a copy of your SF-50 via the Federal Records Center, National Archives and Records Administration.
  • Veteran Documentation: (DD-214, VA Disability Letter, etc.). Reference Standard Form 15 (SF-15) for required documentation if you are a 10-point preference eligible. Submission of SF-15 is not required, unless you have 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 preference eligibles, 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 (Disability Appointment): Documentation of eligibility for employment under Schedule A can 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. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
  • Documentation to support any other noncompetitive or OPM interchange agreement eligibility. Reference the Eligibility section of the questionnaire for required documents and information.
  • Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP)for more information and required documentation.
  
  Please do not submit any other supplementary 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.
• 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 08/30/2024 to receive consideration.
  
  
  1. To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
  2. 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.
  3. 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.
  4. 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/12515745
  5. 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 hrss@nih.gov.
  
  If you need any other accommodation or assistance with applying, please contact NIH HR Service Desk Branch E at ohrcsdbranchesrvdsk@od.nih.gov. 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
  
  NIH HR Service Desk Branch E
  
  Email
  
  ohrcsdbranchesrvdsk@od.nih.gov
  
  Address
  
  National Institutes of Health
  
  6701 Rockledge Drive
  
  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.
• 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

Required Documents

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:

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

If the position has an education requirement or you are qualifying on the basis of education, you need to 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.

ELIGIBILITY/PREFERENCE DOCUMENTATION:

You must submit the following documentation, if applicable to you AND respond accordingly to the associated question on the online questionnaire. 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.

• SF-50 - A copy of your most recent competitive career or career conditional SF-50 that shows the effective date of your latest position and the full performance level. You may obtain a copy of your SF-50 from your human resources office or, if you are an HHS employee, from your eOPF. If you separated from Federal Government employment, you may obtain a copy of your SF-50 via the Federal Records Center, National Archives and Records Administration.
• Veteran Documentation: (DD-214, VA Disability Letter, etc.). Reference Standard Form 15 (SF-15) for required documentation if you are a 10-point preference eligible. Submission of SF-15 is not required, unless you have 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 preference eligibles, 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 (Disability Appointment): Documentation of eligibility for employment under Schedule A can 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. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
• Documentation to support any other noncompetitive or OPM interchange agreement eligibility. Reference the Eligibility section of the questionnaire for required documents and information.
• Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP)for more information and required documentation.

Please do not submit any other supplementary 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.

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 08/30/2024 to receive consideration.

1. To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
2. 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.
3. 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.
4. 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/12515745
5. 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 hrss@nih.gov.

If you need any other accommodation or assistance with applying, please contact NIH HR Service Desk Branch E at ohrcsdbranchesrvdsk@od.nih.gov. 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

NIH HR Service Desk Branch E

Email

ohrcsdbranchesrvdsk@od.nih.gov

Address

National Institutes of Health

6701 Rockledge Drive

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.

Fair & 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