Quality Assurance; QA) Specialist III

The Fountain Group is a national staffing firm and we are currently seeking a Sr. Quality Assurance Specialist
- Pharma Manufacturing for a prominent client of ours. This position is in North Chicago, IL 60064.

Details for the position are as follows:

We are seeking an experienced Senior Quality Assurance Specialist to support pharmaceutical manufacturing quality activities and key quality projects within a regulated environment. This is a 12-month contract opportunity supporting cross-functional quality initiatives, including a product presentation transition from vial to syringe
.

The ideal candidate will have hands-on experience within pharmaceutical manufacturing Quality
, including exposure to aseptic/sterile manufacturing processes
, Quality Systems, and combination products or medical devices.

Schedule: Hybrid - onsite Tuesday through Thursday; remote Monday and Friday

Hours: Monday-Friday, 8:00 AM-5:00 PM

Pay: $41-$44/hour

Travel: Approximately 20%

• Provide Quality Assurance support for pharmaceutical manufacturing operations and ensure compliance with applicable corporate, GMP, and regulatory requirements.
• Support Quality activities associated with pharmaceutical and combination products, including a product presentation transition from vial to prefilled syringe.
• Develop, coordinate, and drive Quality projects across multiple site QA functions.
• Support and coordinate aseptic/sterile manufacturing Quality activities and associated compliance requirements.
• Manage Quality System activities including deviations, investigations, CAPA, nonconformances, change controls, and complaints.
• Coordinate with site Quality teams, project leads, external manufacturing partners, and other cross-functional stakeholders to achieve project deliverables.
• Support Quality activities involving third-party manufacturers and external manufacturing sites.
• Analyze Quality data, metrics, cycle times, process performance, and project deliverables to identify opportunities for improvement.
• Identify project and compliance risks and assist with development and implementation of mitigation strategies.
• Support project charters, requirements, objectives, timelines, action items, and status reporting.
• Support regulatory inspection readiness and activities associated with new product or market introductions.
• Lead or coordinate Quality compliance and performance-improvement initiatives.
• Maintain effective working relationships with internal Quality organizations and Quality teams at third-party manufacturing partners.

• Bachelor's degree required;
  Biology, Chemistry, Life Sciences, Engineering, or a related discipline preferred.
• Approximately 3-5+ years of Quality Assurance experience within pharmaceutical, biotechnology, medical device, or another highly regulated manufacturing environment.
• Experience supporting pharmaceutical manufacturing Quality operations.
• Knowledge of aseptic processing, sterile manufacturing, fill/finish, injectable products, vials, syringes, or similar manufacturing processes.
• Experience with combination products and/or medical devices.
• Strong working knowledge of Quality Systems, including deviations, investigations, CAPA, change control, nonconformances, and/or complaints.
• Understanding of GMP and regulated pharmaceutical manufacturing requirements.
• Strong project management, organization, analytical, and problem-solving skills.
• Excellent written and verbal communication skills with the ability to work effectively across Quality, Manufacturing, project teams, and external partners.
• Ability to work onsite Tuesday through Thursday and travel approximately 20%.

• Experience with aseptic filling, sterile injectable products, prefilled syringes, vials, or drug-delivery systems.
• Experience supporting combination products within a pharmaceutical manufacturing environment.
• External Quality, Supplier Quality, CMO, or third-party manufacturing experience.
• New product introduction, technology transfer, or product-transition experience.
• Experience coordinating cross-functional Quality projects and communicating project status to management.
• Familiarity with electronic Quality Management Systems such as Track Wise or similar QMS platforms.