Quality Assurance Specialist

This position is located in the Department of Health and Human Services, Administration for Strategic Preparedness and Response, headquartered in Washington, District of Columbia. This announcement will close at 11:59 PM, on the day that 100 applications have been received or the closing date of the announcement, whichever comes first.

Basic Qualifications:

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.

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.

• Reviewing production activities and capabilities in light of contract quality requirements.
• Reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans.
• Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system.
• Verifying by test or inspection, using sampling inspection or intensive product inspection techniques, that products comply with requirements prior to acceptance.
• Identifying inadequacies and requesting corrective action.
• Computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods.
• Investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities.
• Reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals.
• Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspections.

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-11 grade level in the Federal service performing ALL of the following:

• Managing product inspection and compliance for medical countermeasures products such as vaccines, therapeutics, etc.
• Interpreting and applying Current Good Manufacturing Practice (cGMP) regulations and guidance.
• Implementing tracking system where all documentation records of product inspection and acceptance are stored.
• 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.

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, Ameri Corps) 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 tha