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Senior Quality Associate
1 week ago
Key Responsibilities
- Develop and maintain quality assurance procedures, policies, and systems related to Manufacturing Execution Systems (MES).
- Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP regulations.
- Collaborate with automation, IT, and production teams to uphold quality standards throughout the manufacturing process.
- Investigate deviations, non-conformities, and implement Corrective and Preventive Actions (CAPA) related to MES quality events.
- Participate in cross-functional teams to ensure consistency across all manufacturing execution systems.
Required Skills and Qualifications
- Bachelor's or advanced degree in Science, Engineering, Quality, or a related discipline.
- Minimum 3 years of experience in quality assurance within biotechnology, pharmaceuticals, or medical device manufacturing.