Regulatory Affairs Specialist
Relocation expenses reimbursed No
In addition, 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 Government obtained in either the private or public sector performing the following tasks: Managing quality assurance programs or initiatives for an aseptic processing facility; developing and analyzing audits and coordinating remediation efforts for aseptic processing facilities; identifying best practices for the continued compliant operations of aseptic processing facilities; and conducting reviews and interpreting FDA and USP regulations/guidance as relates to aseptic processing facilities.
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, student, 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.
Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/10338811
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.
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 a "non-emergency/teleworker" position and the selected candidate will be considered a "nonemergency/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.
- 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.
- A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
- PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration.
- We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement.
- 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.
You will be evaluated for this job based on how well you meet the qualifications above.
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
- - Well Qualified - for those who excel in the evaluation criteria
- - Qualified - for those who only meet the minimum qualification requirements
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 any other requirements. Read more Security clearance Other Drug test required No