Summary The CSP Program Manager manages Compounded Sterile and Non-sterile Products Programs related to regulatory compliance, quality assurance and performance improvement and compliance oversight of all personnel involved compounding. The Program Manager is responsible for developing and implementing procedures; overseeing compliance with all USP chapters and other regulations, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas. Responsibilities Administrative and Program Management: Develops and implements appropriate procedures, oversees, and assures facility compliance with USP Chapters 795, 797, and 800 and other applicable laws, regulations, and standards. Ensures competency of personnel and assuring environmental control of all compounding areas. Reviews sterile and non-sterile compounding policies and procedures Maintains environmental control of the compounding areas and cleanroom primary and secondary engineering controls and ensures they meet environmental standards and validation requirements. Provides education and training of all trainees and employees specific to CSP and hazardous drug management processes Ensures that the decision to outsource CSP preparations or to prepare CSPs locally follows the VHA PBM decision-making hierarchy and associated guidance Assures that outsourced CSPs comply with USP 795, 797, and 800 requirements and meet the United States Pharmacopoeia compendia standards of purity, quality, sterility, and identity. Compounds and dispenses extemporaneous preparations even those which require a high degree of technical and pharmaceutical knowledge. Maintains IV admixture references with up-to-date information to assist pharmacists with accurate processing, compounding/mixing, and dispensing of IV admixtures. Works closely with the Pharmacy ADPAC on the integration of Pharmacy packages. Works with pharmacy personnel and other health professionals to develop and participate in the implementation of quality assurance (QA), performance improvement (PI), and/or research related to pharmacy. Maintains a current knowledge of therapeutics and disease management. Clinical Patient Care, Medication Dispensing and Distribution: Reviews patient medications ensuring they have appropriate diagnosis. Recommends appropriate drug therapy changes based on current standards of pharmacy practice and patient response. Practices formulary management, ensuring the most cost effective and therapeutically appropriate medications are utilized based on individual patient needs. Communicates with providers concerning appropriate medication therapy and solves technical problems independently. Performs all pharmacy distributive functions according to the VHA and local policies to provide comprehensive pharmaceutical services in a timely fashion to meet the needs of our patients and medical center staff. Education and Training: Participates in or directs training of pharmacists, technicians, and students in aseptic technique and other IV functions.? Serves as a mentor in the development and conduct of residency projects. Maintains qualifications (as set forth by ASHP) to serve as a residency preceptor for the PGY1 Pharmacy Residency Program. Ensures the competency of Pharmacy personnel in the preparation of and handling of CSPs through initial, competency assessments, annual training, and standard testing within established timeframes. Work Schedule: 7:30am to 4:00pm from Monday through Friday Telework: Available - Ad-hoc Virtual: This is not a virtual position. Functional Statement #: 000000 Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Requirements Conditions of Employment You must be a U.S. Citizen to apply for this job. All applicants tentatively selected for VA employment in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied employment with VA. Selective Service Registration is required for males born after 12/31/1959. Must be proficient in written and spoken English. You may be required to serve a probationary period. Subject to background/security investigation. Selected applicants will be required to complete an online onboarding process. Must pass pre-employment physical examination. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details. Qualifications Applicants pending the completion of educational or certification/licensure requirements may be referred and tentatively selected but may not be hired until all requirements are met. Basic Requirements: United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy. Education: Graduate of an Accreditation Council for Pharmacy Education (ACPE) accredited College or School of Pharmacy with a baccalaureate degree in pharmacy (BS Pharmacy) and/or a Doctor of Pharmacy (Pharm.D.) degree. Verification of approved degree programs may be obtained from the Accreditation Council for Pharmacy Education, 20 North Clark Street, Suite 2500, Chicago, Illinois 60602-5109; phone: (312) 664-3575, or through their Web site at: http://www.acpe-accredit.org/. (NOTE: Prior to 2005 ACPE accredited both baccalaureate and Doctor of Pharmacy terminal degree program. Today the sole degree is Doctor of Pharmacy.) Graduates of foreign pharmacy degree programs meet the educational requirement if the graduate is able to provide proof of achieving the Foreign Pharmacy Graduate Examination Commission (FPGEC) Certification, which includes passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) and the Test of English as a Foreign Language Internet- Based Test (TOEFL iBT). Licensure. Full, current and unrestricted license to practice pharmacy in a State, Territory, Commonwealth of the United States (i.e., Puerto Rico), or the District of Columbia. The pharmacist must maintain current registration if this is a requirement for maintaining full, current, and unrestricted licensure. A pharmacist who has, or has ever had, any license(s) revoked, suspended, denied, restricted, limited, or issued/placed in a probationary status may be appointed only in accordance with the provisions in VA Handbook 5005, Part II, Chapter 3, section B, paragraph 16. English Language Proficiency. Pharmacists must be proficient in spoken and written English as required by 38 U.S.C. 7402(d), and 7407(d). May qualify based on being covered by the Grandfathering Provision as described in the VA Qualification Standard for this occupation (only applicable to current VHA employees who are in this occupation and meet the criteria). Grade Determinations: In addition to the basic requirements for employment stated above, the following criteria must be met when determining the grade of candidates. GS-13 Facility Program Manager Experience: Must have at least 1 year of experience equivalent to the GS-11 grade level, or completion of an ACPE-accredited Pharm.D. program, and meet the following Knowledge, Skills, and Abilities (KSAs): Knowledge of professional pharmacy practice. Ability to communicate orally and in writing to both patients and health care staff. Knowledge of laws, regulations, and accreditation standards related to the distribution and control of scheduled and non-scheduled drugs and pharmacy security. Skill in monitoring and assessing the outcome of drug therapies, including physical assessment and interpretation of laboratory and other diagnostic parameters. In addition, must have 1 year of experience equivalent to the next lower grade level (GS-12), and meet the following Knowledge, Skills, and Abilities (KSAs): Ability to communicate orally and in writing to persuade and influence clinical and management decisions. Expert understanding of regulatory and quality standards for their program area. Ability to solve problems, coordinate and organize responsibilities to maximize outcomes in their program area or area of clinical expertise. Expert knowledge of a specialized area of clinical pharmacy practice or specialty area of pharmacy. Advanced skill in monitoring and assessing the outcome of drug therapies, including physical assessment and interpretation of laboratory and other diagnostic parameters. Reference: VA Handbook 5005/55 Part II Appendix G15 Licensed Pharmacist dated June 7, 2012. The full performance level of this vacancy is GS-12. The actual grade at which an applicant may be selected for this vacancy is GS-13 Physical Requirements: The work includes some walking, standing, bending, and carrying light items such as paper and books. Most of the work is performed while seated. 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/. Additional Information Receiving Service Credit or Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed. During the application process you may have an option to opt-in to make your resume available to hiring managers in the agency who have similar positions. Opting in does not impact your application for this announcement, nor does it guarantee further consideration for additional positions. This job opportunity announcement may be used to fill additional vacancies. This position is in the Excepted Service and does not confer competitive status. VA encourages persons with disabilities to apply. The health-related positions in VA are covered by Title 38, and are not covered by the Schedule A excepted appointment authority. Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process. If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement. Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative job offer. For more information about the Act and the complaint process, visit Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP) at The Fair Chance Act.