Portland, OR, 97240, USA
1 day ago
Facility Program Manager (Compounding and Hazardous Drug Compliance)
Summary VA Portland Health Care System is a Complexity Level 1a Facility and provides extensive primary, secondary, tertiary, and quaternary care in outpatient, inpatient, residential, and community settings. VAPORHCS is a multi-site medical system that includes a major medical facility in Portland, Oregon, outpatient and residential facilities in Vancouver, Washington, and 10 Community Based Outpatient Clinics. Responsibilities VA Careers - Pharmacy: https://youtube.com/embed/Fn\_ickNBEws The duties of this position include but are not limited to the following: The Pharmacy Compounding Program Manager is responsible for the planning, implementing, and operating of all aspects of the CSP, non-sterile compounding, and hazardous drug programs for the pharmacy service at VA Portland Healthcare System (VAPORHCS). This includes compliance oversight of all pharmacists, technicians, trainees, and other supportive personnel involved in sterile and non-sterile compounding and/or hazardous drug management. The Program Manager is responsible for developing and implementing appropriate procedures; overseeing compliance with all USP chapters and other applicable laws, regulations, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas. The Program Manager is responsible for the development, organization and management of the Sterile and Non-Sterile Compounding program in compliance with all applicable laws and regulations (e.g., Joint Commission, USP 797, 795, 800, OIG, FDA, DEA, NIOSH etc. and any future regulations in this area) for VAPORHCS Pharmacies. To support these programs, the incumbent is responsible for developing and implementing appropriate procedures; monitoring compliance; ensuring competency of personnel; and ensuring environmental control of storage and compounding areas. The Program Manager is responsible for maintaining reports of testing/sampling performed in the pharmacy areas and acting on the results. The Program Manager is responsible for oversight of automation systems associated with CSP and non-sterile compounding. Thorough knowledge and understanding of various regulations including FDA, DEA, USP, NIOSH, OIG and the Joint Commission and VHA national and local handbooks and directives, policies and standard operating procedures pertaining to the practice of pharmacy is required. The Pharmacy Compounding Program Manager must have knowledge of contemporary drug distribution systems including outpatient prescription processing, unit dose, and IV admixtures. The pharmacist must have a working knowledge of VISTA, CPRS, and other software used in the operation of pharmacy automation systems. The incumbent will work with Chief of Pharmacy, or designee, to change procedures when necessary. The incumbent is responsible for various teaching functions including, but not limited to educational presentations to house staff, continuing education presentations to pharmacy staff, and staff in-services. The pharmacist will serve as an active member of committees as requested by the Chief of Pharmacy. Develops and implements appropriate policies and procedures; oversees and assures facility. Compliance with USP Chapters 795, 797, and 800 and other applicable laws, regulations, and standards. Reviews sterile and non-sterile compounding policies and procedures at minimum every 2 years or more frequently as needed and recommends updates. Communicates updates and provides training as needed to affected employees. Monitors activities of all personnel involved with compounding to ensure compliance with USP Chapters 795, 797, and 800 and other applicable laws, regulations, and standards. Coordinates quality assurance monitoring and evaluation involved with compounded sterile preparation and hazardous drug management operations. 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. Develops educational initiatives and provides education and training of all pharmacy service trainees and employees specific to CSP, non-sterile compounding, and hazardous drug management processes. Maintains environmental control of the compounding areas and cleanroom primary and secondary engineering controls and ensures they meet environmental standards and validation requirements for viable and non-viable airborne sampling and testing. Ensures that results of all action levels from sampling of both viable and non-viable airborne particulate and other sample testing are reviewed by the Pharmacy Management and the Sterile Compounding Committee with appropriate corrective actions. Is present during hood certification and testing (or assigns competent designee) to assure established standards are met. Work Schedule: Monday-Friday 08:00am-4:30pm Telework: Not Authorized Virtual: This is not a virtual position. Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized PCS Appraised Value Offer (AVO): 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 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: (1) 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 (NOTE: Prior to 2005 ACPE accredited both baccalaureate and Doctor of Pharmacy terminal degree program. Today the sole degree is Doctor of Pharmacy.) (2) 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). TRANSCRIPTS REQUIRED 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. LICENSURE REQUIRED English Language Proficiency. Pharmacists must be proficient in spoken and written English as required by 38 U.S.C. 7402(d), and 7407(d). Grade Determinations: In addition to the basic requirements for employment, the following criteria must be met when determining the grade of candidates. Grade Determinations: Facility Program Manager, GS-13. Experience. In addition to the GS-12 requirements, must have 1 year of experience equivalent to the next lower grade level. Pharmacists assigned to this position must demonstrate 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: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/. The full performance level of this vacancy is GS-13. Physical Requirements: The work requires light lifting and carrying (under 15 pounds); reaching above shoulder; use of fingers; walking (up to 1 hour); standing (up to 1 hour); near vision correctable at 13" to 16" to Jaeger 1 to 4; ability to distinguish basic colors; and hearing (aid may be permitted). 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.
Confirm your E-mail: Send Email