Senior Compliance QA Specialist: GMP Excellence & Audits

Indivior PLC; Raleigh (NC); Vor Ort; USD 88.000 - 108.000; Vollzeit

Zusammenfassung

Indivior PLC seeks a Sr. Specialist, Compliance QA for the Raleigh site to strengthen quality systems. You will author Annual Product Reviews, manage change control and CAPA records, and draft Quality Agreements while driving regulatory compliance.

You will coordinate self-inspections, participate in customer and regulatory audits, and ensure inspection readiness with ERP and GDocs processes. Strong technical writing, audits, and cross‑functional collaboration are essential.

Qualifikationen

• Bachelor’s Degree in life sciences, engineering, or a related technical discipline from an accredited university.
• Minimum five (5) years GMP/GXP Pharmaceutical experience.
• In‑depth knowledge of current GMP/GXP as well as FDA trends and guidelines.
• Experience authoring Annual Product Reviews.
• Experience conducting internal audits (Certified Quality Auditor preferred).
• Excellent technical writing skills and technical reviewer experience.
• Effective verbal and written communication with all levels of employees on all aspects of compliance.
• In‑depth knowledge of quality assurance terminology, methods, and compliance tools.
• Computer skills required; experience with Veeva preferred.
• Experience reviewing lab data and audit trail data preferred.
• Organized, detail‑oriented, capable of handling multiple tasks and redirecting focus based on company needs.
• Adaptable to schedule changes, shifts in priority and cross‑functional task alignment.
• Proficient in problem‑solving and risk mitigation.
• Team focused, motivated and foster a positive and accepting environment.
• Travel: Less than 10% travel

Aufgaben

• Distribute components, raw materials, and bulk product release of systems for use.
• Develop, implement, and maintain systems and procedures to ensure a high level of inspection readiness and regulatory compliance.
• Participate in multi‑functional project teams as a Quality Compliance representative as directed by the CQA Manager or Site Quality Director.
• Develop and drive compliance initiatives based on new regulations, guidance documents, industry standards, and Indivior global procedures as they apply to the site.
• Function as a change controller and CAPA manager for site records.
• Facilitate the compilation of data and author the Annual Product Review reports.
• Author Quality Agreements.
• Create the self‑inspection schedule, perform self‑inspections, write audit reports, and follow up on observations and non‑conformances.
• Participate in customer and regulatory audits, as required.
• Participate in the review and approval of GMP documents including procedures, validation protocols, engineering documents and critical work orders.
• Coordinate vendor‑initiated changes and vendor complaints.
• Responsible for compiling and reporting metrics related to site compliance.
• Perform QA review and approval of incoming materials in the ERP system, as required.
• Provide support and guidance to ensure GDocs are applied throughout the Raleigh Site.
• Track open records in eQMS to include deviations, environmental excursions, OOS investigations, CAPAs, and change controls to closure.
• Design and implement action plans to ensure compliance with procedural requirements.
• Perform lab data review as needed.
• Other duties and responsibilities as assigned

Kenntnisse

Technical writing

Verbal communication

Attention to detail

Problem solving

Risk mitigation

Cross-functional collaboration

Ausbildung

Bachelor’s Degree in life sciences/engineering

Tools

Veeva

Jobbeschreibung

Indivior PLC seeks a Sr. Specialist, Compliance QA for the Raleigh site to strengthen quality systems. You will author Annual Product Reviews, manage change control and CAPA records, and draft Quality Agreements while driving regulatory compliance.

You will coordinate self-inspections, participate in customer and regulatory audits, and ensure inspection readiness with ERP and GDocs processes. Strong technical writing, audits, and cross‑functional collaboration are essential.