The Research Regulatory Affairs-Facilities organization within ORSC provides regulatory support for the various cGMP and compounding facilities on campus. Support includes guidance in meeting the regulatory requirements with regards to facility design and facility operations. The area maintains centralized resource contracts such as for specialized cleaning and preventative maintenance, will aid in FDA Inspections of facilities, aide in development of Quality Systems, and responses to audits.
Summary
The Research Regulatory Affairs-Facilities organization within ORSC provides regulatory support for the various cGMP and compounding facilities on campus. Support includes guidance in meeting the regulatory requirements with regards to facility design and facility operations. The area maintains centralized resource contracts such as for specialized cleaning and preventative maintenance, will aid in FDA Inspections of facilities, aide in development of Quality Systems, and responses to audits.
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.
As a GS-0601-14 Supervisory Regulatory Affairs Specialist in the Clinical Center, your duties may include but are not limited to the following:
Planning and assigning work to be accomplished by subordinates, developing performance standards and evaluating staff performance, and identifying ways to improve production or increase the quality of the work directed.
Using regulatory knowledge of the requirements for cGMP and compounding facilities; selects, qualifies and oversees the speciality contracts for cleaning services, pest management, environmental monitoring (to include indentification of specific disinfectents based on the microbial results from monitoring), materials management and vendor qualifications for suppliers.
Providing regulatory support for investigators from NIH Institutes performing FDA regulated research including assisting investigators in meeting the Food and Drug Administration requirements and in reviewing and preparing protocols.
Using expertise in FDA and USP regulations and guidance, identifies and designs customized audit and evaluation surveys for each facility, develops protocols to evaluate and validate internal and external research facilities to ensure they meet the regulatory statutes and NIH manufacturing and compounding quality requirements.
Preparing reports, briefings, project papers, correspondence and presentations for the Chief and may be requested to make presentations.
Providing expertise in FDA and USP regulations, standards and guidance with the design team to ensure that the facility will be in compliance with pertinent regulations and state of the art facility specifications.
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.)
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.
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts.
At the supervisors discretion, this position may offer work schedule flexibilities: telework, alternative work schedules, and maxiflex.
If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
This position is designated as a "emergency essential" position. See definition of this designation in the Additional Information Section of this announcement.
If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450. See the Additional Information Section of this announcement for more information.
Qualifications
Education Qualification Requirement:
In order to qualify for a Supervisory Regulatory Affairs Specialist-GS-601, position you must have successfully completed a full 4 year course of study in an accredited college or university leading to a Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained).
Additional Qualification Requirement for GS-14:
In addition, in order to qualify for a Supervisory Regulatory Affairs Specialist-GS-601, at the GS-14 level, you must have at least one (1) year of qualifying specialized experience equivalent to at least the GS-13 level in the Federal Government obtained in either the private or public sector performing the following types of tasks: Leading or supervising a subordinate staff responsible for providing regulatory affairs related support for an aseptic processing facility; identifying and developing audits and evaluation surveys for the compliance of aseptic processing facilities; providing regulatory consultation to clinical investigators and clinical staff on aseptic processing facility operations research protocols and procedures; overseeing and reporting on regulatory functions impacting clinical research and recommending corrective action plans; interpreting FDA and USP regulations/guidance as relates to aseptic processing facilities; and preparing reports of audit finding and recommendations.
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.
You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.
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
If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
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.
A one-year supervisory trial/probationary period may be required upon selection/ placement.
If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/topics/fd.html.
Diversity, equity, inclusion, and accessibility (DEIA) is a core competency for the Clinical Center (CC) so candidates are required to submit a diversity statement describing their commitment to promoting DEIA as evident in a track record of activities within their resume/cover letter. If invited for an interview the candidate will be required to describe their record of promoting diversity and inclusion such as, but not limited to, mentoring individuals from underrepresented groups, participating in mentoring programs designed to promote diversity, and DEIA-related outreach activities.
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.
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. Knowledge of the principles, theories, and methods of quality assurance and quality improvement, as relates to aseptic manufacturing and compounding facility operations.
2. Ability to plan, evaluate, and audit processing/compounding facility operations.
3. Knowledge of FDA and USP regulatory compliance procedures and protocol guidelines.
4. Ability to lead and supervise others.
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 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 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.
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)
Performance ratings and any monetary or non-monetary awards
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.
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.
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.
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 02/03/2023 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/11806534
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 Jacaranda Guzman Vargas at guzmanvargasja@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
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.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
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)
Performance ratings and any monetary or non-monetary awards
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.
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.
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.
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 02/03/2023 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/11806534
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 Jacaranda Guzman Vargas at guzmanvargasja@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
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.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
