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As a Quality Assurance Specialist, you will: Establish clearly defined quality assurance processes, procedures and documentation. Ensure that all documents are controlled by managing a document control program. Manage the review and approval of all procedures, guidance documents, manuals and policies. Ensure all required procedures and records are in place and meet the applicable regulatory requirements. Ensure CAPA investigations are conducted, root causes are determined and corrective and preventive actions are implemented. Coordinate regular audits of OADLSS processes, procedures and products. Issues written audit findings to senior OD leaders and partner officials documenting any operational deficiencies observed. Develop an end of year report on the status of the QMS. Develop a comprehensive QMS for the OD to meet ISO 9001 standards. Coordinate internal and external audits of OD processes to meet ISO 9001 standards.

US Citizenship is required. Background Investigation is required. 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. All qualification requirements must be met by the closing date of the announcement. One-year probationary period may be required. Travel, transportation, and moving expenses may be paid: No Drug Screening Required: No Annual Leave for non-federal service may be authorized: No Promotion potential: No Supervisory position: No Public Trust/Moderate Background Investigation (5) is required.

Requirements Continued: In accordance with Executive Order 12564 of September 14, 1986, The Department of Health and Human Services (HHS) is A Drug-Free Federal Workplace. The Federal government, as the largest employer in the Nation, can and should show the way towards achieving drug-free workplaces through programs designed to offer drug users a helping hand, and at the same time demonstrating to drug users and potential drug users that drugs will not be tolerated in the Federal workplace. The use of illegal drugs, on or off duty, by Federal employees is inconsistent not only with the law-abiding behavior expected of all citizens, but also with the special trust placed in such employees as servants of the public. Applicants tentatively selected for this position may be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to reasonable suspicion and post-accident drug testing upon hiring. If required to submit to urinalysis, the appointment to the position will be contingent upon a negative applicant drug test result. In order to demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring. Current or Former Political Appointees: Agencies must seek prior approval from the Office of Personnel Management (OPM) before they can appoint a current or recent political appointee to a competitive or non-political excepted service position at any level under the provisions of title 5, United States Code. If you are currently, or have been within the last 5 years, a political Schedule A, Schedule C, or Non-career SES employee in the executive branch, you MUST disclose that to the Human Resources Office. Failure to disclose this information could result in disciplinary action including removal from Federal Service. Current or Former Political Appointees: Submit SF-50. Minimum Qualifications: To qualify at the GS-13 grade level, you must have at least one year of specialized experience at or equivalent to the next lower grade level, which must include the following experience: developing and/or directing a quality management program, specifically with experience in ISO compliance and/or directing a quality management program in a laboratory (i.e. biomedical). 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.

$104008.0 to $135209.0/PA

Full-Time