Quality Assurance Specialist
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
The Center for Veterinary Medicine (CVM) is an internationally recognized, high performance, public health organization. Our mission is to protect human and animal health. To achieve this, CVM reviews animal drug applications for safety and effectiveness, monitors animal drugs, animal foods, and devices on the market, reviews food additives for safety and utility, and conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals. CVM fosters human and animal health by approving safe and effective products for animals and by enforcing applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. These include animals, from which human foods are derived, as well as pet (or companion) animals.
Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee's contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow.
Who May Apply: All United States citizens.
This position is located in the Food and Drug Administration, Office of Foods and Veterinary Medicine, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Division of Business Information Science and Management, Quality Assurance Team in Rockville, Maryland.
This vacancy is also being announced concurrently with vacancy announcement FDA-CVM-18-MP-10054869MF under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. Applicants must apply separately for each announcement in order to be considered under both options.
Relocation expenses reimbursed No
Additional Conditions of Employment:
- Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
- E-Verify: If you are selected for this position, the 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. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
- Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
- Pre-employment physical required: No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- Immunization required: No
- Bargaining Unit Position: Yes
- Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
All qualification requirements must be met by 11:59 pm (Eastern Time) on 10/19/2017. In order to qualify for Quality Assurance Specialist, 1910, at GS - 12/13, you must meet the following:
Selective Placement Factor
You possess one year of regulatory quality assurance experience conducting quality assurance reviews of clinical and/or nonclinical laboratory studies in support of drug approvals to determine compliance with regulatory requirements.
You must possess a degree with a major study of quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position.
Possess one year experience that demonstrates a practical knowledge in monitoring, controlling or maintaining the quality of products or services in quality assurance, procurement, inspection, production or related areas.
- Experience 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 inspection.
Minimum Qualifications for GS-12
You must possess one year of specialized experience equivalent to at least the GS-11 level in the Federal service. This experience includes developing, implementing, and/or executing programs, plans, or projects to achieve and maintain quality assurance under Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; performing quality assurance reviews/assessments of drug study reports to ensure compliance with Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; and providing guidance on laws, regulations, and guidelines governing quality assurance programs/plans in a regulatory environment. This experience must be reflected in your resume. Volunteer experience can also be used as qualifying experience.
Minimum Qualifications for GS-13
Possess one year of specialized experience equivalent to at least the GS-12 level in the Federal service. This experience includes developing, implementing, and/or executing programs, plans, or projects to achieve and maintain quality assurance under Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; performing quality assurance reviews/assessments of drug study reports to ensure compliance with Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; providing guidance on laws, regulations, and guidelines governing quality assurance programs/plans in a regulatory environment; and developing and conducting quality assurance compliance audits for a regulatory environment. This experience must be reflected in your resume. Volunteer experience can also be used as qualifying experience.
You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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. For further information, click on foreign education.
Additional selections may be made within the same geographical area FDA-wide.
- If you are serving, or have served in the last 5 years (from 10/19/2017) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM
- Veteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
- Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.
- Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Disability Employment
- Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Workforce Restructuring
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 ET on 10/19/2017), 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 or not you are qualified for this particular position.
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.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Interview Process: Structured interviews; may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: work samples, conducting a presentation, reference checks, tests may be used.
Basis of Rating: Category rating procedures 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 assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
- Quality Assurance Program Management
- Regulatory Compliance Management
- Technical Advisor