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Manufacturing Quality Assurance Specialist
2 weeks ago
About the Role:
The QA Manufacturing Support Scientist plays a pivotal role in ensuring the quality of our products. As part of the Manufacturing Operations team, you will be responsible for enforcing compliance with procedures and GMP requirements.
Your primary responsibilities will include providing real-time review of manufacturing records and logbooks, ensuring manufacturing compliance, and working with Manufacturing Operations to resolve issues.
- Ensure the manufacturing line is set up according to batch documentation and associated SOPs.
- Conduct batch record 'Stage Approval' as part of the batch release process.
- Participate in Gemba walks of the production area and conduct specific site systems audits.
- Review and approval of validation/qualification documentation.
- Work with manufacturing to drive improvements in GMP compliance across all shifts.
Education and Experience:
- Bachelor's and/or Master's degree in Natural Sciences.
- Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, medical laboratory technology including 3-5 years experience within a GMP environment in the Pharma Industry.
- Strong working knowledge of the principles and guidelines for GMP is a plus.
