Highlights
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. 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.
Numbers & Facts
| Location | North Chicago, IL |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Year Founded | 1969 |
| Website | http://www.sterling-engineering.com |
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%
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.
About Company
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.