Quality Program Specialist at Orsini Healthcare

Elk Grove Village, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Aug, 26

Salary

24.0

Posted On

01 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, CAPA Tracking, Complaint Management, Document Control, Internal Auditing, External Auditing, Trend Analysis, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Visio, Project Management, Data Analysis, Interpersonal Communication, Problem Solving, Electronic Medical Records Review

Industry

Pharmaceutical Manufacturing

Description

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 may be required to perform other assignments not listed in this job description. QUALIFICATIONS 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 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 Requirements Work Type: Remote Travel: Travel %: ≤15% Equal Employment Opportunity Orsini 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 Act Applicants 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 Notice We 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.pdf Right to Work Poster (English & Spanish): https://www.e-verify.gov/sites/default/files/everify/posters/IER_RightToWorkPoster.pdf

Responsibilities

The Quality Program Specialist supports the implementation and maintenance of the Quality Management System, focusing on complaint management, CAPA tracking, and document control. The role also involves conducting audits, reviewing electronic medical records for safety reporting, and ensuring regulatory compliance.