22 Feb

Quality Assurance Specialist Jobs Vacancy in Department Health And Human Services Laurel

Quality Assurance Specialist
Department Health And Human Services
Laurel MD
22 Feb, 2018 29 days ago

Department Health And Human Services Laurel urgently required following position for Quality Assurance Specialist. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Quality Assurance Specialist Jobs Vacancy in Department Health And Human Services Laurel Jobs Details:


    • Summary

      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

      This position is located in the Food and Drug Administration, Office of Foods and Veterinary Medicine, Center for Veterinary Medicine, Office of Research in Laurel, Maryland.

      This vacancy is also being announced concurrently with vacancy announcement FDA-CVM-18-MP-10136975 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.

      Additional selections may be made within the same geographical area FDA-wide.


      The Office of Research (OR), Center for Veterinary Medicine (CVM) conducts applied research in support of decision-making related to each of CVM's core functions. OR is located in a state-of-the-art research complex in Laurel, MD; the 166-acre campus includes laboratories as well as 38 acres of pasture. To support CVM's drug review program, the Office of Research conducts studies to evaluate animal drug safety and effectiveness, antimicrobial resistance mechanisms, and metabolism, as well as to standardize test methods. To support CVM's compliance program, the Office develops analytical methods and evaluates screening tests for detection of drug residues in imported and domestic food products. The Office also has an animal feed safety research program for developing and evaluating microbiological and analytical methods for detection of natural and intentional contaminant

      As a Quality Assurance Specialist in the Office of Research, you will be responsible for performing laboratory audits, evaluations, and inspections to verify conformance to Good Laboratory Practice (GLP) compliance regulations. You will also implement standard operating procedures for the evaluation and monitoring of research to ensure the accuracy, reliability, reproducibility and timeliness of reported test results and data. This involves ensuring that standard operating procedures, protocols, and schedules essential to Quality Assurance audits are established and adhered to.

      Travel Required

      Not required

      Supervisory status No

      Promotion Potential 12

    • Job family (Series) 1910 Quality Assurance

    • Requirements


      Conditions of Employment

      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.
    • U.S. Citizenship is required for Federal employment.
    • Selective Service registration required for certain males based on DOB.
    • Background check to determine suitability for Federal employment.
    • 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: No
    • 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.
    • Financial disclosure statement, OGE-450, required: No


    In order to qualify for Quality Assurance Specialist, 1910, at GS - 11, you must meet the following:

    Selective Placement Factor:
    One year of regulatory quality assurance experience conducting quality assurance reviews of nonclinical laboratory studies to determine compliance with Food and Drug Administration Good Laboratory Practice regulatory requirements.

    Basic Requirement:
    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; (or) possess a combination of graduate education and professional experience. Examples of professional experience includes: Perform audits, evaluations and inspections to verify conformance to Good Laboratory Practice (GLP) compliance regulation; implement policies and standards for the evaluation & monitoring of research; ensure Standard Operating Procedures, (SOP) protocols and audit schedules are adhered to.
    Examples includes:
    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.


    Specialized Experience:

    Possess one year of experience, equivalent to at least the GS-9 level in the Federal service, experience includes conducting quality assurance audits to evaluate laboratory operations for compliance with the Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations and auditing protocols, raw data, data summary tables and final reports associated with nonclinical laboratory studies to ensure protocol requirements are met and followed by the FDA GLP regulations (or) possess 3 years of progressively higher level graduate education, leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree. This experience must be reflected in your resume. Volunteer experience can be used as qualifying experience.


    If you are qualifying based on education, 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 information

    If you are serving, or have served in the last 5 years (from 03/07/2018) 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 Appointees FAQ - OPM
    • Veteran's Preference: If you plan to apply for any kind of Veteran 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

    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 ET on 03/07/2018) 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 Process Management
  • Law & Regulations
  • Risk & Opportunity Management
  • To review the application questionnaire, click the link below.

    Background checks and security clearance

    Security clearance Q - Nonsensitive

  • Required Documents

    Required Documents

    The following documents are ACCEPTED for this vacancy:
    • Cover Letter
    • DD-214
    • Supporting Documents
    • VA Letter
    • Resume
    • SF-15
    • SF-50
    • Transcript

    "Accepted" means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.

    The following documents are REQUIRED for this vacancy:
    • Resume

    "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.

    • Veterans: veteran eligibility documentation (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.
    • Persons with Disabilities : Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
    • Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM Guide to Career Transition for more information.

    If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

    Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

  • Benefits


    A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits .

    Review our benefits

    Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.

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