The Sr. Compliance Specialist supports the Quality and Compliance systems at the Raleigh facility. This role is responsible for the management of Change Control and CAPA records, the authoring of Quality Agreements and APQRs and the site self-inspection program.
Requirements
- 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 Head.
- Develop and participate in compliance initiatives based on new regulations, guidance documents and industry standards.
- Function as a change controller and CAPA manager for site records.
- Facilitate the compilation of data, and author the Annual Product Quality 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, but not limited to procedures, validation protocols, engineering documents and critical work orders.
- Manage 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 GDocPs 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.
- Drive compliance initiatives based on new regulations, guidance documents, industry standards and Indivior global procedures as they apply to the site.
- Perform lab data and audit trail review as needed.
- Other duties and responsibilities as assigned
Benefits
- 3 weeks’ vacation plus floating holidays and sick leave
- 401(k) and Profit Sharing Plan
- U.S. Employee Stock Purchase Plan
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health, Dependent Care and Limited Purpose Flex Spending and HSA options
- Adoption assistance
- Tuition reimbursement
- Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
- Gym, fitness facility and cell phone discounts
