The Quality Assurance Specialist will be working at the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), in the VA Cooperative Studies Program, a VA Central Office Program as a tenant of the Albuquerque VA Medical Center (VAMC) in Research Service in Albuquerque, NM. Specializing in very large-scale clinical research studies within the VA, the Cooperative Studies Program (CSP) has conducted many studies to advance the practice of medicine.

Duties

***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds. Duties will include but may not be limited to the following: Plans, develops, implements, and administers a wide variety of quality assurance management systems and procedures to support clinical trials for the inspection, storage, handling, manufacturing and packaging of pharmaceuticals and medical devices supporting complex national clinical trials and research programs. Develops, implements, and assures effective quality control procedures customized to every study, by identifying, proofing, measuring, and analyzing customer requirements in relation to established procedures to determine adequacy, reliability, and validation of processes, to promote process and product quality, and ensure continuous process improvement. Develops, implements, and maintains Master Production Records as to the overall specifications for the quality of every drug and medical device used for each clinical trial. Develops sampling plans and calculates required assay and retained sample needs to support stability and release protocols. Approves label designs to ensure conformance to cGMP regulations. Leads Process Action Teams (PATs); coordinates and promotes technical quality control (QC) functions and performs quality assurance (QA) operations throughout the facility to ensure that adequate quality provisions are planned, developed, and implemented. Interfaces with suppliers, production staff and customers to select, analyze, and audit various processes and identify methodologies for process improvement to enhance customer satisfaction and ensure successful completion of clinical trials. Serves as a technical expert in FDA regulatory requirements for drugs and medical devices. Works with study team members to establish drug assay specifications, quality metrics and product acceptance standards for cGMP compliance. Communicates with key officials, managers, contractors, and other individuals within and outside the agency concerning quality matters or investigations, and to seek guidance for establishing acceptance standards or critical quality parameters of drugs or devices. Provides informal and formal guidance and instruction to production personnel and contractors, regarding deficiency corrections, inadequate production performance, and other non­conforming product improvement and disposal. Mentors and assists in the training of other QC personnel, and in providing quality control, procedural and cGMP training to all staff. Performs other duties as assigned. Work Schedule: Monday - Friday 8:00 am - 4:30 pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not approved Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.

Requirements

Qualifications

For GS-9: SPECIALIZED EXPERIENCE: Possess at least one (1) year of specialized experience equivalent to the next lower grade level of (GS-7) in Federal service. Specialized 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. OR EDUCATION: Possess a master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related. 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. NOTE: One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. (TRANSCRIPTS REQUIRED) OR COMBINATION OF EDUCATION AND SPECIALIZED EXPERIENCE: Possess a Combinations of successfully completed post-high school education and experience may be used to meet total qualification requirements for the grade levels. To be computed by first determining the total qualifying experience as a percentage of the experience required for the grade level; then determining the education as a percentage of the education required for the grade level; and then adding the two percentages. The total percentages must equal at least 100 percent to qualify for the grade level. Only graduate education in excess of the amount required for the next lower grade level may be used to qualify applicants for positions at grade GS-9. (TRANSCRIPTS REQUIRED) For GS-11: SPECIALIZED EXPERIENCE: Possess at least one (1) year of specialized experience equivalent to the next lower grade level of GS-9 in Federal service. Specialized 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. OR EDUCATION: Possess a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. 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. NOTE: One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. (TRANSCRIPTS REQUIRED) OR COMBINATION OF EDUCATION AND SPECIALIZED EXPERIENCE: Possess a Combination of successfully completed post-high school education and experience may be used to meet total qualification requirements for the grade levels. To compute by first determining the total qualifying experience as a percentage of the experience required for the grade level; then determining the education as a percentage of the education required for the grade level; and then adding the two percentages. The total percentages must equal at least 100 percent to qualify for the grade level. Only graduate education in excess of the amount required for the next lower grade level may be used to qualify applicants for positions at grade GS-11. (TRANSCRIPTS REQUIRED) This position includes two (2) Selective Placement Factors (skill, knowledge, ability or other worker characteristic basic to - and essential for - satisfactory performance of the job). Selective Placement Factors are a prerequisite to appointment and represent minimum requirements for a position. Applicants who do not meet it are ineligible for further consideration. The Selective Placement Factor for this position is: 1. I Possess knowledge of the unique requirements of current Good Manufacturing Practices (cGMP). 2. I possess and knowledge of multiple standards and regulations governing healthcare clinical research. You will be rated on the following Competencies as part of the assessment questionnaire for this position: Customer ServiceManufacturingProduction and ProcessingQuality Management IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. 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.

Education

For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.

Physical Requirements: The work requires the occasional lifting up to 401bs., climbing on ladders, the use of pallet jacks and other material handling equipment (MHE), and other activities related to a warehouse environment.


IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.


NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: Recognition of Foreign Qualifications | International Affairs Office (ed.gov).

Contacts

• Address Albuquerque ORD VISN 22 1501 San Pedro Drive, Southeast Albuquerque, NM 87108 US
• Name: VHA National Recruitment Center
• Phone: (844)456-5208
• Email: [email protected]