Quality Assurance Specialist

About the role

The Quality Assurance Operation Technical Specialist provides routine technical support for GMP manufacturing operations across multi-product manufacturing, fill, and finish facilities. This on-site role focuses on cross-functional deviation investigations, corrective and preventive actions (CAPAs), audit support, targeted innovations, and initiatives that enhance overall plant performance. The specialist collaborates closely with Quality, Operations, Continuous Improvement, Engineering, MSAT, and Project Management teams to support site objectives and must be able to work an on-call schedule to provide technical support and site deviation analysis when needed. This is primarily an office-based position within GMP manufacturing facilities, with regular visits to the manufacturing floor to communicate directly with subject matter experts and observe processes. The role involves working closely with cross-functional teams in a structured, regulated environment focused on pharmaceutical manufacturing, fill, and finish operations. Standard business software tools such as Microsoft Word, Excel, and Outlook are used routinely. The position requires being on site and available for on-call technical support and deviation analysis as needed. This is a Contract to Hire position based out of Grand Rapids, MI.

Responsibilities

• Execute routine technical support activities for GMP manufacturing operations across multi-product manufacturing, fill, and finish facilities.
• Lead and participate in cross-functional deviation investigations to identify root causes and propose effective corrective and preventive actions.
• Develop, document, and implement CAPAs and action items (AIs) to address process deviations and improve manufacturing performance.
• Support audit preparation and audit activities by providing technical documentation, data, and explanations related to quality operations.
• Contribute to targeted innovation projects aimed at improving plant performance, process robustness, and overall operational efficiency.
• Collaborate closely with Quality