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Quality Assurance Operations Supervisor
2 months ago
Exciting Opportunity: Senior Quality Assurance Associate
Company Overview: Baxter is a leading global pharmaceutical organization committed to enhancing and preserving lives. With a legacy spanning over 85 years, Baxter has consistently driven medical advancements that revolutionize healthcare. We invite you to become part of our dedicated team, where we specialize in the production of bone hemostats and synthetic bone graft materials.
Job Responsibilities:
- Assist in the batch review process to ensure compliance
- Authorize the release of raw materials and components for production
- Compile and analyze release data for final products
- Ensure resolution of deviations before product approval
- Oversee document management activities
- Facilitate quality investigations
- Engage in internal and supplier audits
- Support regulatory compliance inspections
- Manage statistical process controls
- Contribute to cross-functional project teams
Qualifications:
- Bachelor's degree in a scientific, technical, or engineering discipline preferred
- A minimum of 2 years of experience in a GMP environment
- Familiarity with ISO13485, FDA regulations, and GMP practices
- Experience in cleanroom settings and sterile manufacturing processes
- Excellent communication abilities