The Cooperative Studies Program (CSP), The Department of VA CSP is an Agency Program as a division of VHA's Office of Research and Development (ORD), CSP's mission is to advance the health and care of veterans and the nations through cooperative research studies that produce innovative and effective solutions to national healthcare problems. Specializing in very large-scale clinical research studies within the VA, across the United States, and Internationally.

Duties

Duties include, but are not limited to: The QA Pharmaceutical Project Manager (QAPPM) is responsible for and manages pharmaceutical quality assurance of national multicenter clinical trails (hereinafter referred to as MCT) with budgets ranging from $550K to 50M per MCT. The QAPPM is a member of the Center's Division of Study Design and Management, which is staffed with QAPPMs and Clinical Research Pharmacists that are designated as the Projects Directors (PDs) of the MCTs that the PCC supports. This division provides pharmaceutical science and logistical support to these trials. The QAPPM has a direct line of responsibility for the quality assurance of DSDM services and products. The incumbent is also involved in negotiating with pharmaceutical or device companies, manufacturing, packaging, labeling, laboratory testing (identification, potency, dissolution, shelf life determination), supply calculation, procurement scheduling, central distribution, retrieval, inventory accountability, and destruction of clinical materials and frequently the collection, receipt, processing, storage and retrieval of bio-specimens. The incumbent is responsible for systematically monitoring and evaluating the service and products provided to an MCT to ensure that the desired level of quality is being met with the primary aim of focusing on process. Works with the PD to determine the scope and QbD aspects of MCTs and documents all related changes to the project's pharmaceutical design, budget and, controls and design targets, goals, and objectives, procedures, action plans and timeframes. Uses computer software (e.g. MS Project, etc.) to define and establish the QbD to task sequence and milestones to accomplish these major MCTs, on time and within budget and coordinates daily activities of the MCT with PCC's cross functional section teams. Identifies the customers (site investigators, nurse coordinators, research pharmacists) that will receive PCC product and servives. Identifies any special needs for the project (e.g., special packaging, specials labeling, special handing, etc. Assists the PD in developing the features of the design that will meet the needs of the project (i.e., operationalizing the Research Health Care Treatment Models). Responsible for working with the computer software developers in the Information Systems Section to ensure quality (QbD) is built into the design and development of web-based application for randomization assignments and inventory control and clinical material accountability at the participating clinical sites. Oversees and manages the QbD aspects of clinical materials inventory levels at the PCC and the clinical sites and the scheduling and generation of weekly and monthly automated inventory orders. responsible for record-keeping of PCC support to the assigned MCTs. Designs and implements quality databases, spreadsheets, and interim reporting systems to manage large MCTs over several years. Ensures QBD compliance with CSP, PCC standard operating procedures (SOPs), approved methods and procedures (AMPs), CSP guidelines, and VA and other Federal regulations governing MCTs. Promotion Potential: The selectee may be promoted to the full performance level without further competition when all regulatory, qualification, and performance requirements are met. Selection at a lower grade level does not guarantee promotion to the full performance level. VA offers a comprehensive total rewards package: 2023 VHA Total Reward$ of a Nonclinical Professionals VA Career Brochure.pdf Work Schedule: Monday to Friday, 8:00AM - 4:30PM Compressed/Flexible: Position not suitable Telework: This position is authorized for telework. Virtual: This is not a virtual position. Position Description/PD#: Quality Assurance Specialist/PD02949A, PD02948A, and PD02947A Relocation/Recruitment Incentives: Not authorized Critical Skills Incentive (CSI): Not authorized Permanent Change of Station (PCS): Not authorized Financial Disclosure Report: Not required.

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 09/29/2023. 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 GS11 position you must have served 52 weeks at the GS9. 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: At the GS11: Must have one year of work experience with quality assurance and quality by design or project management. At the GS12: Must have two years of work experience with quality assurance and quality by design or project management. This position has an Individual Occupation Requirement (IOR). You must meet one of the following: 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. In addition to meeting the IOR above, you must meet the experience and/or education as described below: GS-11 Specialized Experience: You must have one year of specialized experience equivalent to at least the the next lower grade(GS-9) in the normal line of progression for the occupation in the organization in the Federal service. Examples of specialized experience would typically include, but are limited to: Perform quality assurance check for monitoring/auditing reports, summaries, and attachments that are submitted by field monitors/auditors; Collect data from monitoring/auditing site visits and provides quality assurance trending analyses of GCP compliance and noncompliance data; Prepare statistical and analytical reports to document and verify completion of program activities, goals, objectives and action plans; Track site visits and report status, verifying completion of reports during the specified time frames; Provide website training to internal staff and remote monitors and auditors. Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 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 with a Major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position. OR, Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education as described above beyond the second year of Graduate Level education. See above to compute this eligibility. Specialized Experience at the GS12: You must have one year of specialized experience equivalent to at least the next lower grade (GS-11) in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: knowledge of quality control and assurance, including statistical analysis, sampling, and reporting techniques; knowledge and experience with regulations as they apply to packaging, labeling, storage and distribution; planning, developing, and implementing quality systems; knowledge for evaluating product standards, characteristics, and technical specifications as they apply to quality levels achieved on products or packaging. Specialized Experience at the GS13: You must have one year of specialized experience equivalent to at least the next lower grade (GS-12) in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Manage pharmaceutical quality assurance of national multicenter clinical trials; Independently generates progress quality reports both for internal sections and outside collaborating agencies and industries; Plan multicenter clinical trial projects in advance, via Quality by Design, for providing services and producing and distributing clinical materials (drugs, devices, ancillary supplies); Coordinate with internal and external organizations to obtain quality assurance data and information needed to satisfy regulatory requirements. You will be rated on the following Competencies for this position: Customer ServiceProject ManagementQuality AssuranceQuality Management 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. Physical Requirements: Work requires periods of walking, standing, and bending in offices, conference rooms, the laboratory, the bio-repository, clinical materials management and clinical manufacturing areas. Employee frequently carry light items such as books, instruments, drug/device products, and other similar materials. The work does not require any extraordinary special physical effort. 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: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address Raymond G Murphy Department of Veterans Affairs Medical Center 1501 San Pedro Drive, Southeast Albuquerque, NM 87108 US
• Name: Cesar Ruiz Jimenez
• Phone: 310-478-3711
• Email: [email protected]