Careers with real impact.Every role at Orsini moves a patient closer to life-changing therapy. We partner with biopharma innovators, healthcare providers, and payers to make access simple, compassionate, and reliable - so no patient is left behind. Make your next role matter.ABOUT ORSINIProviding compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™OUR MISSIONOrsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™. CORE VALUESAt the heart of our company culture, the Orsini
LIVE IT Core Values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. POSITION SUMMARYThe Quality Program Specialist supports the implementation and maintenance of the Quality Management System at Orsini, including issues and complaint management, deviation and CAPA tracking, document control, quality checks, and internal/external audit preparation and follow-up.This role is responsible for executing assigned quality processes, maintaining accurate documentation, and ensuring timely completion of quality tasks. The Quality Program Specialist coordinates day-to-day quality activities, gathers and analyzes data, prepares reports, and provides support with other aspects of the quality system as needed.This role helps ensure the provision of optimal pharmaceutical care to patients and clients of Orsini Healthcare and ensure compliance with all applicable regulatory and accreditation standards.ESSENTIAL RESPONSIBILITESSupport issue, complaint, deviation, and CAPA managementSupports management of service issues and complaints, ensuring accuracy, completeness, and timely follow-up and resolution. Coordinates with cross-functional teams to facilitate appropriate and timely closure. Performs trend analysis to identify patterns and recurring risks. Facilitates deviation and CAPA activities, including tracking, documentation, and follow-up. Support audits and audit readiness activitiesSupports and conducts audits to assess compliance with regulatory, industry, and accreditation standards. Documents audit findings and tracks observations in the Quality Management System. Collaborates with management to support timely remediation of identified deficiencies. Assists in audit readiness activities, including preparation for external audits and accreditation surveysReview electronic medical records for safety event reporting accuracyReviews electronic medical records to verify correct reporting and documentation of safety events. Identifies errors, omissions, or potential compliance issues and escalates or addresses them as appropriate. Maintain quality documentation and document control processesMaintains quality documentation within the Quality Management System. Ensures proper version control and routing for review and approval. Supports compliance with Orsini, client, regulatory, and accreditation requirements. Participate in special projects and support ongoing quality initiativesParticipates in special projects and quality initiatives as necessary. Performs other duties as assigned to support departmental and organizational priorities. Other duties and responsibilities as required.Disclaimer: The information written in this job description indicates the general nature and level of work to be performed. This job description is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description. QUALIFICATIONSHigh School Graduate or equivalent combination of education and experience required 1-3 years of related experience Strong computer skills – Microsoft Excel, Word, PowerPoint, Visio Excellent interpersonal, written and verbal communication skills Previous quality management experience preferred Ability to identify, analyze, and solve complex problems Ability to aggregate, analyze and make inferences from data Good project management skills Ability to respond to changing priorities and handle multiple tasks at one time Preferred:Associate’s Degree or equivalent combination of education and experience Prior specialty pharmacy experience 4-5 years of related experience Work Environment & Travel RequirementsWork Type: Remote Travel: Travel %: ≤15% Equal Employment OpportunityOrsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws.Americans with Disabilities ActApplicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.E-Verify Participation NoticeWe participate in the federal E-Verify program to confirm the identity and employment eligibility of all newly hired employees.All offers of employment are contingent upon the successful completion of Form I-9 and verification through the E-Verify system.For more information about E-Verify, please review the official notices below:E-Verify Participation Poster (English & Spanish):https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdfRight to Work Poster (English & Spanish):https://www.e-verify.gov/sites/default/files/everify/posters/IER_RightToWorkPoster.pdf
