Clarification from the agency

Current/Former Federal Employees (Status Candidates) serving on a career or career-conditional competitive appointment including Land & Base Management employees, Veterans and Military Spouses, People with Disabilities (Schedule A), CTAP/ICTAP, Family of Overseas Employees, Peace Corps, PHS Commissioned Corps, and Special Authorities

• Uses mastery of quality management concepts, operating principles, and methodology applicable to perform auditing/assessment activities by scheduling, coordinating, and conducting internal audits/assessments.
• Conducts inspections of facilities and research studies, including animal use studies, to support defined quality management systems by identifying areas for continuous improvement aid.
• Carries out assigned duties in a manner consistent with the safety policies defined by the supervisor.
• Submits written reports, including checklists, of internal audit/assessment results to the Principal Investigators, Laboratory Personnel and Division Directors as appropriate in a timely fashion.
• Applies quality control systems and quality assurance methods to determine risks and compliance standards for work and implements associated risk mitigation actions.
• Reports safety hazards, potentially hazardous situations, and close calls to the supervisor. Assists the supervisor to identify and eliminate un-safe conditions.
• Provides consultation for effective corrective/preventive actions when laboratory safety and/or data quality and integrity or compliance have been compromised.

Conditions of employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• Selective Service Registration: All applicants males born on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
• THIS POSITION IS SUBJECT TO EXECUTIVE ORDER 14043 MANDATING COVID-19 VACCINATION FOR FEDERAL EMPLOYEES. See section titled Next Steps for more Conditions of Employment for this position.

Qualifications

The position of Quality Assurance Specialist falls under the 1910 occupational series. To qualify for this position at grade GS-13, you must meet Time-in-Grade requirements by 11:59 pm EST on 12/13/2021.

Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement.

Basic Requirement: Applicants must (1) have undergraduate and graduate education in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position OR (2) have 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 include:

• 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.

In addition to meeting the Basic requirement above, applicants must meet the specialized experience below:

Specialized Experience: Applicants musthave one year of specialized experience equivalent to the next lower grade of GS-12 or equivalent band level of responsibility in the federal service utilizing research related quality assurance concepts, such as data quality and/or integrity evaluation techniques. Applicants must also have experience performing trend analysis, monitoring and/or determining compliance in quality managements systems within a research laboratory.

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.

If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply!

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application.

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.

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.

You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran, individual with a qualifying disability, or a displaced employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for details.
Be sure that any files you upload as supporting documentation are free of security or compression features which render such documents unreadable to our system.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm EST on 12/13/2021), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.
If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.
If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities. Additionally, we will review your supporting documents and resume to determine if you are in the "Area of Consideration" for this vacancy. Government-Wide Merit Promotion vacancies may only accept applications from a limited audience, pay careful attention to the "Who May Apply" and the "Hiring Paths" information. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of three categories: Best Qualified, Well-Qualified or Qualified.
Interagency / Career Transition Assistance Program (I/CTAP):Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies.