Sr. Specialist, Compliance QA

Indivior • Raleigh, NC

5d • $88,000 - $108,000 • Onsite

About The Position

The Sr. Specialist supports the Quality and Compliance systems at the Raleigh facility. This role is primarily responsible for authoring Annual Product Reviews (APRs), conducting site self-inspections, management of Change Control and CAPA records, and authoring of Quality Agreements. The Sr. Specialist will have a high level of interaction and influence within the site and is expected to drive improvements to the systems for which the role is responsible.

Requirements

• Bachelor’s Degree in life sciences, engineering, or a related technical discipline from an accredited university required.
• Minimum five (5) years GMP/GXP Pharmaceutical experience required.
• Must have an in-depth knowledge of current GMP/GXP as well as FDA trends and guidelines.
• Must have experience authoring Annual Product Reviews.
• Must have experience conducting internal audits, Certified Quality Auditor preferred.
• Must have excellent technical writing skills and technical reviewer experience.
• Must be able to communicate effectively both verbally and in writing 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.
• Must be organized, detailed, and have ability to handle multiple tasks at once and redirect focus based on company's needs.
• Must be adaptable to schedule changes, shifts in priority and cross-functional task alignment.
• Proficient with problem-solving and risk mitigation.
• Must be team focused, motivated and foster a positive and accepting environment.

Nice To Haves

• Certified Quality Auditor preferred.
• Experience with Veeva preferred.
• Experience reviewing lab data and audit trail data preferred.

Responsibilities

• Distribution of 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, but not limited to 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 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.
• Perform lab data review as needed.
• Other duties and responsibilities as assigned

Benefits

• Eligible to participate in Indivior’s bonus program, based on company and individual performance
• Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan
• Competitive PTO plus company closure from December 24th- January 1st
• 401(k) and Profit-Sharing Plan- Company match
• U.S. Employee Stock Purchase Plan- 15% Discount
• 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
• Wellness programs as well as other discounts and perks

What This Job Offers

• Job Type: Full-time
• Career Level: Senior