Supervisory Quality Management Scientist
Occasional travel - You may be expected to travel for this position.
Relocation expenses reimbursed No
Successful completion of a full 4-year course of study in an accredited college or university, leading to a bachelor's or higher 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.
Additional Qualification Requirements:
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal Government. performing the following types of tasks: Leading, supervising, and/or directing, Quality Assurance work to be accomplished for a registered and licensed blood and cellular therapy product manufacturing organization; reviewing and recommending improvements to standard operating procedures (SOPs) and instructions for all QA activities; Implementing departmental policies for SOP standards, validation, and implementation, product recalls, error and accident reports, and workplace safety and infection control; Confirming that SOPs are in compliance with all applicable regulations of the FDA the Standards of the American Association of Blood Banks (MBB); Acting as a liaison with the FDA for all lnvestigational New Drug (IND) applications for biologics prepared by the organization.
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.
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 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.
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.htm.
A one-year supervisory trial/probationary period may be required upon selection/ placement
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