This position is located in the Department of Health and Human Services, Administration for Strategic Preparedness and Response, headquartered in Washington, District of Columbia.

Duties

WHAT YOU'LL BE DOING DAY TO DAY As a Quality Assurance Specialist, you will use your knowledge of and experience with Administration for Strategic Preparedness and Response (ASPR) to optimize business results and customer experience by: Performing critical duties required to ensure that the SNS maintains a comprehensive quality control and that cGMP standards and other regulatory guidelines are adhered to by SNS staff and contract partners during the receipt, storage, handling, transport, and shipping preparation of pharmaceuticals products. Conducting regular inspections of SNS facilities to document cGMP compliance and identify deficiencies; reviews facility data and documentation including, but not limited to, equipment validations, document control system, temperature monitoring, product cold chain, deviations, corrective and preventive actions (CAPAs), preventive maintenance. Ensures that all quality assurance requirements such as SOPs and protocols are in place, controlled, and meet cGMP and other regulatory requirements. Meeting with program officials and key staff in the ASPR, HHS, and other Federal agencies, along with key contract partner representatives, members of the science- based academic community, and industry to resolve issues associated with the administration and execution of quality control programs.

Requirements

• U.S. Citizenship required
• Males born after December 31, 1959 must be registered or exempt from Selective Service - http://www.sss.gov
• Suitable for federal employment
• Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. All information concerning qualifications is subject to investigation.
• Documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.
• All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choice.
• All qualification requirements must be met by the closing date.
• Financial disclosure statement may be required.
• Probationary (or trial) period may be required.

Qualifications

WHAT WE ARE LOOKING FOR Basic Qualifications: Education Undergraduate and Graduate Education: Major study -- quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position. or Experience that demonstrated a practical knowledge in monitoring, controlling, or maintaining the quality of products or services in quality assurance, procurement, inspection, production, or related areas. Examples can be found at : Quality Assurance Series 1910 (opm.gov) Minimum Qualifications: You must have one year specialized experience to perform successfully the duties of the position. To be creditable, specialized experience must have been equivalent to at least the GS-12 grade level in the Federal service performing ALL of the following: 1. Managing product inspection and compliance for medical countermeasures products such as vaccines, therapeutics, etc. 2. Interpreting and applying Current Good Manufacturing Practice (cGMP) regulations and guidance. 3. Implementing tracking system where all documentation records of product inspection and acceptance are stored. 4. Conducting manufacturing facility/site product inspection and acceptance for regulatory compliance. Documenting experience: IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. Do not copy and paste the duties, specialized experience, or occupational application questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the "percentage of times" the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. 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; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited. OPM Qualification General Policies Website

Education

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov.


Note: Applications can be accepted from students who expect to complete qualifying education within 9 months from the date of application. Education was completed successfully before the applicant can be appointed.

Contacts

• Address Administration for Strategic Preparedness and Response 200 Independence Ave. SW Washington, DC 20201 US
• Name: SROC Help Desk
• Email: [email protected]