Quality Program Specialist

Orsini Healthcare•Elk Grove Village, IL

4d•$24 - $24•Remote

About The Position

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. 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™ 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™. 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.

Requirements

High 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
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

Nice To Haves

Previous quality management experience preferred
Associate’s Degree or equivalent combination of education and experience
Prior specialty pharmacy experience
4-5 years of related experience

Responsibilities

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.