What are the responsibilities and job description for the Quality Assurance Specialist III position at Katalyst CRO?
Job Summary
The QA Senior Specialist will provide quality assurance support for pharmaceutical manufacturing operations, ensuring that products, processes, systems, and quality activities comply with applicable corporate standards, regulatory requirements, and Good Manufacturing Practices (GMP). The role will lead and coordinate quality projects across multiple QA functions, drive process improvements, monitor key performance metrics, support regulatory inspections and new market introductions, and partner with internal stakeholders and Third-Party Contractors (TPCs) to maintain a robust quality culture.
Roles & Responsibilities
The QA Senior Specialist will provide quality assurance support for pharmaceutical manufacturing operations, ensuring that products, processes, systems, and quality activities comply with applicable corporate standards, regulatory requirements, and Good Manufacturing Practices (GMP). The role will lead and coordinate quality projects across multiple QA functions, drive process improvements, monitor key performance metrics, support regulatory inspections and new market introductions, and partner with internal stakeholders and Third-Party Contractors (TPCs) to maintain a robust quality culture.
Roles & Responsibilities
- Plan, coordinate, and drive the execution of quality assurance projects across multiple site QA functions. Partner with site QA planners and cross-functional stakeholders to achieve project milestones and deliverables.
- Coordinate with centralized/global quality functions to support the deployment of global Pharma 3 initiatives.
- Analyze and maintain data related to cycle times, touch times, task lists, and process activitie s to identify opportunities for QA process optimization.
- Drive the development, improvement, and maintenance of QA planning and scheduling processes.
- Ensure QA functions within project scope implement and maintain effective visual management tools to monitor critical quality processes and performance.
- Analyze and report metrics related to planned and unplanned QA activities, identifying trends, risks, and opportunities for improvement.
- Proactively identify project and compliance risks and implement appropriate risk assessments, mitigation plans, and fallback strategies.
- Lead the development of Project Charters, including project objectives, stakeholder requirements, deliverables, success criteria, and project governance.
- Lead or coordinate compliance, quality, and performance improvement initiatives and provide regular project status updates to site management.
- Support regulatory inspections, including activities associated with new market introductions and product registrations.
- Collaborate with QA, manufacturing, engineering, regulatory, and other cross-functional teams to ensure effective implementation of quality initiatives.
- Maintain effective communication and cooperative working relationships with Third-Party Contractors (TPCs) and their Quality organizations.
- Promote continuous improvement and ensure sustained compliance with applicable GMP, corporate quality standards, and governmental regulations.
- Support quality activities across the product lifecycle, from raw material inspection through final product shipment.
- Bachelor's degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biotechnology, Engineering, or related scientific/technical discipline.
- A master's degree in a relevant scientific, pharmaceutical, or quality-related field is preferred.
- 5-8 years of experience in Quality Assurance/Quality Systems within the pharmaceutical, biotechnology, medical device, or related regulated industry.
- Strong experience with GMP, Quality Systems, compliance, deviation/CAPA management, change control, and quality risk management.
- Demonstrated experience leading or coordinating cross-functional quality and continuous improvement projects.