Sr. Quality Assurance Specialist

Job Description

Job Description

Job Title: Senior Quality Assurance Specialist | Pharmaceuticals

Location: North Chicago, IL
Hire Type: Long-term contract position (1 year +)
Pay Rate: $40.00/hour
Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), & ESOP
Work Schedule: Hybrid | Remote Monday & Friday; On-Site Tuesday–Thursday | 8:00 AM–5:00 PM
Travel: Up to 20%

Job Summary:

We are seeking a Senior Quality Assurance Specialist to provide Quality Assurance support for a pharmaceutical manufacturing project. This role will support a new project for a key product and ensure product, process, and system-related quality activities comply with applicable corporate and governmental regulations.

The Senior QA Specialist will lead and coordinate Quality projects across multiple site QA functions, manage project deliverables and metrics, identify and mitigate risks, and provide project updates to site management.

Must-Have Skills:

• Quality Systems: Strong understanding of pharmaceutical Quality Systems and compliance requirements.
• Communication: Excellent verbal and written communication skills with the ability to work across multiple QA functions.
• Project Management: Experience planning, coordinating, and driving Quality projects from initiation through completion.
• Aseptic Processing: Familiarity with aseptic manufacturing processes and associated quality requirements.
• Combination Products: Experience or familiarity with combination product environments.

Job Duties:

• Develop, coordinate, and drive execution of Quality projects across multiple site QA areas.
• Coordinate with site QA planners to achieve project deliverables and timelines.
• Support deployment of global pharmaceutical Quality initiatives across the site.
• Analyze and maintain data related to cycle times, touch times, tasks, and processes to improve QA performance.
• Support development and maintenance of QA planning and scheduling activities.
• Implement and maintain visual management tools to monitor key QA processes and performance.
• Analyze and report metrics for planned and unplanned QA activities.
• Identify project and process risks and develop mitigation or contingency strategies.
• Lead development of Project Charters, project objectives, requirements, and success criteria.
• Support regulatory inspections related to new market introductions.
• Lead or coordinate Compliance and Performance Improvement projects and provide project status updates to site management.
• Maintain effective relationships with internal Quality functions and third-party contractors.

Qualifications:

• Bachelor's degree in Science, Engineering, Quality, or a related field preferred.
• Experience in pharmaceutical manufacturing, Quality Assurance, or a highly regulated environment.
• Experience managing or coordinating cross-functional Quality projects.
• Working knowledge of Quality Systems and regulatory compliance.
• Familiarity with aseptic processing and/or combination products.
• Strong analytical, organizational, and project management skills.
• Excellent communication and interpersonal skills.
• Ability to identify risks, develop mitigation strategies, and drive projects to completion.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.