Quality Program Specialist

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 ORSINI

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™.  

CORE 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.  

COMPENSATION & LOCATION

The compensation is $24.00 per hour.
This position is remote.

POSITION SUMMARY

The 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 RESPONSIBILITES

Support issue, complaint, deviation, and CAPA management 

• Supports 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 activities 

• Supports 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 surveys

Review electronic medical records for safety event reporting accuracy 

• Reviews 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 processes 

• Maintains 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 initiatives 

• Participates 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 ma