This position is located within the Division of Quality Assurance (DQA) Quality Control (QC) Section of the Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. The incumbent manages quality assurance and quality control functions of assigned Studies and projects to meet current Good Manufacturing Practice requirements and FDA regulations for the manufacture, processing, packaging, and holding drug products and of the criteria set forth for the specific project at hand.

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 07/23/2024. Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-07 position you must have served 52 weeks at the GS-09. For a GS-09 position you must have served 52 weeks at the GS-11. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. SELECTIVE PLACEMENT FACTOR (SPF): A selective placement factor represents knowledge, skills, or abilities that are essential for successful job performance and cannot reasonable be acquired on the job during the orientation period. Applicants who do not possess the identified SPF will not be considered. The SPF for this position is: Knowledge of the unique requirements of cGMP manufacturing. Knowledge of VA, FDA, and other regulations and standards governing health care research. This knowledge is required to ensure continued compliance and that reported results of the research are credible and accurate. You must meet the basic Individual Occupational Requirements (IMR): Education Undergraduate and 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. or Experience in fields such as quality control, quality inspection, contracting and purchasing, supply and storage, industrial or production planning, research and engineering, maintenance, and test and evaluation that provided (1) familiarity with quality assurance or related work, (2) pertinent product or process knowledge and skill, (3) ability to interpret and apply contract requirements and engineering specifications, and (4) skill in dealing with others in person-to-person work relationships. Specialized Experience: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. You may qualify based on your experience and/or education as described below: Specialized Experience: Substantial knowledge as well as broad experience on how to manage multiple multicenter projects with competing demands and a competing need for resources and maintain compliance with all applicable rules and regulations. Significant experience applying information management to the principles, procedures, and tools of quality management and reliability to ensure that a procedure, process, or audit fulfills requirements and standards. Substantial experience working and communicating with customers and staff to satisfy their needs. OR, Education: To qualify based on education for this grade level you must have successfully Successful completion of 2 years of progressively higher-level graduate education leading to a master's degree or master's or equivalent graduate degree for a GS-09 and a Master's or equivalent graduate degree GS-11 in an accredited college or University. OR, Combination: Applicants may also combine education and experience to qualify at the GS-09 level. You must have a combination of 6 months equivalent to at least a GS-07 level for specialized experience and education beyond one year of graduate-level education for GS-09. Applicants may also combine education and experience to qualify at the GS-11 level. You must have a combination of 6 months equivalent to at least a GS-09 level and education beyond 2 years of progressively higher-level graduate education leading to a master's degree or master's or equivalent graduate degree for GS-11. 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; religions; 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. Note: A full year of work is considered to be 35-40 hours of work per week. 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. 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/.

Education

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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.

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]