This position is located within the Cooperative Studies Program (CSP), Clinical Research Pharmacy Coordinating Center (CRPCC) of the New Mexico VA Healthcare System in Albuquerque, New Mexico. Serving as a Quality Assurance Pharmaceutical Project Manager (QAPPM), this position is responsible for and manages pharmaceutical quality assurance of national multicenter clinical trials.

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-13. At the GS-11 and GS-12 grade levels, 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-13. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds. Monitors and evaluates the services and products provided to multicenter clinical trials (MCT) to ensure the desired level of quality is being met; Plans MCT projects in advance, via Quality by Design (QbD), for providing services, producing, and distributing clinical materials (i.e. drugs, devices, ancillary supplies, etc.); Works with the Project Director to determine the scope and QbD aspects of clinical trials and documents all related changes; Identifies deviations and modifications for preventive and quality improvement changes; Assists in developing the features of a design that will meet the needs of the project; Works with computer software developers to ensure quality is built into the design and development of web-based applications for randomization assignments and inventory control; Develops or adapts existing processes to produce services and clinical supplies/inventory, develop process controls, perform formal risk assessments, and identify opportunities to mitigate risks; Involved in negotiating with pharmaceutical or device companies (to include manufacturing, packaging, labeling, laboratory testing, 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); Participates with developing short- and long-term strategic planning goals, objectives, action plans and quality process improvement strategies; Uses computer software (e.g. MS Project, etc.) to define and establish the QbD task sequence and milestones to accomplish major MCTs, on time and within budget; Coordinates daily activities of the MCT with PCC's cross functional section teams; Responsible for record-keeping of PCC support to the assigned clinical trials; Performs other related duties as assigned. Work Schedule: Monday through Friday, 8:00am - 4:30pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not approved Financial Disclosure Report: Not Required 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

To qualify for this position, all applicants must meet one of the follow: Specialized Experience: You must have at least one (1) year of specialized experience equivalent to the next lower grade level of (GS-9) in Federal service that has given me the particular knowledge, skills and abilities required to successfully perform the duties of this position and demonstrated a practical knowledge in monitoring, controlling or maintaining the quality of services in quality assurance, 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; Verifying compliance requirements are met; 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 systems operations and procedures through periodic audits and surveillance inspections. At this level applicants should possess sufficient experience to be able to provide training to internal staff and remote monitors and auditors. NOTE: Applicants wishing to receive credit for such experience must clearly indicate the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Education: Successful completion three (3) full years of progressively higher-level graduate education or doctoral degree (Ph.D. or equivalent) related to this position. This education must have been obtained at an accredited college or university. NOTE: If you select this option, you must submit a copy of your transcript with your application. Education cannot be credited without documentation. Please ensure that your transcripts show that a degree was conferred. Display copies of degrees or course listings do not provide the information needed. Combination: Equivalent combinations of successfully completed progressively higher-level graduate education (beyond the second year/master's level) and specialized experience, as described above, which meet the total experience requirements for this grade level. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. NOTE: If you select this option, you must submit a copy of your transcript with your application. Education cannot be credited without documentation. Please ensure that your transcripts show that a degree was conferred. Display copies of degrees or course listings do not provide the information needed. You will be rated on the following Competencies as part of the assessment questionnaire for this position: Customer Service (Clerical/Technical)Data ManagementProject ManagementQuality Assurance 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. Physical Requirements: Work requires periods of walking, standing, and bending in offices, conference rooms, the laboratory, the biorepository, 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

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: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

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]