The Quality Assurance (QA) Associate is a vital role responsible for supporting and executing the site's Quality Management System (QMS). You will provide independent quality oversight of manufacturing, packaging, testing, and distribution to ensure all operations remain in a state of control and compliant with global regulatory standards, including 21 CFR Parts 210/211 and EU GMPsResponsibilities:Documentation & Compliance: Perform detailed reviews of bat
The Quality Assurance (QA) Associate is a vital role responsible for supporting and executing the site's Quality Management System (QMS). You will provide independent quality oversight of manufacturing, packaging, testing, and distribution to ensure all operations remain in a state of control and compliant with global regulatory standards, including 21 CFR Parts 210/211 and EU GMPsResponsibilities:Documentation & Compliance: Perform detailed reviews of bat
As our Gatesville site's Quality Guru, you'll be the go-to subject matter expert for solving quality puzzles. You'll facilitate the "Handling of Quality Problems," manage equipment calibration, and ensure everything meeting the ISO 9001 gold standard. You aren't just checking boxes; you're ensuring excellence.Responsibilities:Problem Solver: Spot manufacturing issues and lead the meeting to decide how to fix them.The Auditor: Check our internal systems to
As our Gatesville site's Quality Guru, you'll be the go-to subject matter expert for solving quality puzzles. You'll facilitate the "Handling of Quality Problems," manage equipment calibration, and ensure everything meeting the ISO 9001 gold standard. You aren't just checking boxes; you're ensuring excellence.Responsibilities:Problem Solver: Spot manufacturing issues and lead the meeting to decide how to fix them.The Auditor: Check our internal systems to
The QC Microbiology Environmental Monitoring (EM) Specialist is responsible for maintaining the quality and integrity of manufacturing facilities and processes. This role focuses on supporting environmental monitoring programs, cleaning and maintaining cleanrooms, and ensuring strict compliance with regulatory requirements. The specialist collaborates with cross-functional teams to identify contamination risks and helps develop protocols to safeguard produ
The QC Microbiology Environmental Monitoring (EM) Specialist is responsible for maintaining the quality and integrity of manufacturing facilities and processes. This role focuses on supporting environmental monitoring programs, cleaning and maintaining cleanrooms, and ensuring strict compliance with regulatory requirements. The specialist collaborates with cross-functional teams to identify contamination risks and helps develop protocols to safeguard produ
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