Quality Specialist

This is what you will do

This position provides hands on Quality support to ensure safe, effective, and compliant Chiesi USA products reach patients. The role performs operational quality activities under the guidance of Quality leadership and in alignment with cGMP and internal procedures.

You’ll be responsible for:

• Product Quality Support: Provide quality support on Chiesi USA, Inc. commercial product(s) under guidance from senior level Quality.  
  
  • Review batch documentation and prepare materials supporting disposition of product for the US market.
  • Perform batch disposition–related activities for products stored at 3PLs (e.g., pulling documentation, preparing disposition packages, tracking release status).
  • Initiate product complaints in accordance with internal procedures and ensure timely handoff for evaluation and processing.
  • Support compliance activities to ensure handling, manufacturing, and distribution of products meet quality agreements, cGMP expectations, and internal SOPs.
  • Build effective working relationships through clear communication and follow through.
  • Pull KPI and Quality System performance metrics and draft initial reports to support Quality leadership meetings and routine operational reviews.
• Document Control Support:
  
  • Carry out basic Document Control tasks, including document routing, formatting, template alignment, and document number issuance.
  • Support periodic review management within Hermes, including tracking due dates and following up with document owners.
  • Generate and distribute monthly Hermes document expiration reports.
  • Archive forms, files, and controlled documents in accordance with retention procedures.
• Training Support:
  
  • Assist with assigning training plans in the Learning Management System (LMS) for staff based on role, job function, and onboarding requirements. 
  • Pull reports from the training system to support compliance monitoring, audits, and internal reviews. 
  • Perform virtual and/or in-person new-hire Quality training covering relevant SOPs, systems, and QMS expectations.
• Support of Government Agency Requirements: Ensure compliance to government agencies.
  
  • Support activities required to maintain compliance with applicable government agencies.
  • Assist during FDA inspections and other regulatory interactions as needed.
  • Maintain current understanding of applicable FDA regulations, CFR requirements, and relevant guidance documents.

You will need to have

• BS/BA in Chemistry, Pharmaceutical Science, or Biologic Science from an accredited university or equivalent experience.
• 3+ years experience Quality Assurance in the Pharmaceutical industry.
• Proficiency in reading, interpreting, and evaluating CFR, regulatory guidance, company policy and procedures.
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines. 
• Basic knowledge in MS Office (Word, Excel, MS Outlook), Adobe, Trackwise, SAP and EDMS.

Location

Hybrid role based in Cary, NC.