Quality Assurance Specialist III

Katalyst CRO; North Chicago (IL); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a QA Senior Specialist to provide quality assurance support for pharmaceutical manufacturing operations, ensuring GMP compliance and adherence to corporate standards.

The role will lead and coordinate quality projects across multiple QA functions, drive process improvements, monitor KPIs, and support regulatory inspections and product registrations with internal stakeholders and Third-Party Contractors (TPCs).

Qualifications

• Must have strong GMP knowledge and exposure to QA systems.
• Experience leading cross-functional quality and continuous improvement projects.
• Familiarity with regulatory inspections and product registrations.

Responsibilities

• Plan, coordinate, and drive QA projects across multiple site QA functions.
• Coordinate with centralized/global quality functions to support initiatives.
• Analyze and maintain data related to QA activities to identify optimization opportunities.
• Drive QA planning and scheduling process improvements.
• Ensure visual management tools monitor critical quality processes.
• Analyze metrics and report trends, risks, and opportunities.
• Identify risks and implement mitigation plans and fallback strategies.
• Lead development of Project Charters and governance.
• Lead or coordinate regulatory inspections and product registrations.
• Collaborate with QA, manufacturing, regulatory, and engineering teams.
• Maintain communication with Third-Party Contractors and their Quality orgs.
• Promote continuous improvement and sustained GMP compliance.
• Support quality activities across the product lifecycle.

Skills

QA project coordination

GMP knowledge

Quality systems

Data analysis

Risk management

Cross-functional collaboration

Regulatory inspections

Project governance

Education

Pharmacy

Pharmaceutical Sciences

Chemistry

Biology

Microbiology

Biotechnology

Engineering

Related field

Tools

QMS software

Deviation/CAPA tooling

Change control systems

Quality metrics dashboards

Job description

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.

• 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.

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

• 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.

Education & Experience

• 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.