Description
About Orsini Specialty Pharmacy
Providing 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 Mission
Orsini 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™.
LIVE IT Values
At 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.
Leading Quality, Integrity, Valued Partner, Empathy, Innovation, Team-First
Pay Range: $19-$24 Hourly
Position Summary
The Quality Assurance Specialist will be responsible for supporting the Quality Team in carrying out the quality management systems at Orsini, with a primary focus on internal audits and quality checks. This role will assist in monitoring compliance with contracts, regulatory requirements and accreditation standards by performing safety data quality checks and routine audits, documenting findings and supporting corrective actions. The specialist will also provide support with other aspects of the quality system as needed, which may include vendor management, quality metrics, deviation and CAPA tracking, and document control. By assisting in these activities, the specialist helps ensure the provision of optimal pharmaceutical care to patients and clients of Orsini Healthcare.
Required Knowledge, Skills & Training
• Previous experience in a pharmacy, healthcare quality, or compliance setting required; specialty or mail-order pharmacy experience preferred.
• Knowledgeable in electronic medical record systems and able to navigate and review patient charts for accuracy and completeness required
• Experience with internal audits or compliance monitoring is preferred.
• Familiarity with pharmacovigilance activities, including adverse event reporting and case management, preferred.
• Familiarity with pharmacy accreditation standards (URAC, ACHC, or similar) a plus.
• Strong computer skills – Microsoft Excel, Word, PowerPoint, and Visio
• Strong attention to detail with excellent organizational and documentation skills.
• Effective written and verbal communication skills.
• Ability to follow structured processes and work independently while collaborating across teams.
Essential Job Duties
• Review electronic medical records to verify correct reporting and documentation of safety events.
• Review electronic medical records and patient charts to identify errors, omissions, or potential compliance issues.
• Conducts audit of pharmacovigilance case reports, adverse event documentation and related records to ensure accuracy, completeness, and compliance with contractual obligations
• Maintain organized and accurate records of audits, quality checks, and related documentation.
• Support other aspects of the quality management system as needed
• Special projects as assigned.
Employee Benefits
- BCBSL Medical
- Delta Dental
- EyeMed Vision
- 401k
- Accident & Critical Illness
- Life Insurance
- PTO, Holiday Pay, and Floating Holidays
- Tuition Reimbursement