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.

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

• 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 a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Tier II Emergency Essential Position.
• Position requires Education Please submit transcripts.
• 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. 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; 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. 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. 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 with 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 knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12476256

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.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: NIH HR Service Desk Branch E
• Email: [email protected]