Sr. Specialist, Compliance QA

About the role

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.

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
• 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
• Review and approve GMP documents including, but not limited to procedures, validation protocols, engineering documents and critical work orders
• Capture and report metrics related to site compliance
• Support and guide the application of GDocs across 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

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

Qualifications

• Must have an in-depth knowledge of quality assurance terminology, methods, and compliance tools
• Must be proficient with problem-solving and risk mitigation
• Must be team focused, motivated and foster a positive and accepting environment

Skills

• Excellent technical writing skills and technical reviewer experience
• Organized, detailed, and able to handle multiple tasks at once
• Adaptable to schedule changes, shifts in priority and cross-functional task alignment
• Problem-solving and risk mitigation skills
• Team-focused and fosters a positive and accepting environment

Benefits

Note actual salary is based on qualifications and experience
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