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Senior Quality Assurance Professional
3 weeks ago
This is a high-profile opportunity for an experienced Quality Assurance professional to join our team. As part of our global supply quality team, you will be responsible for supporting oversight and maintenance of contract manufacturers.
- Ensure batch disposition activities are completed in line with Amgen standards as a disposition manager.
- Manage and drive Quality records to closure including deviation records, investigation reports.
- Initiate Quality records for supplier related changes.
- Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed.
- Provide data to the networks to support Quality Management Processes.
- Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements.
The ideal candidate will have a minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
Key skills include:
- A positive impact on others; ability to affect the behaviors of others by connecting with and inspiring them.
- Previous experience in batch release activities.
- Good working knowledge of SAP.
- Experience in investigations, project management and trending and analysis a benefit.
- Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
- Understanding of industry requirements/expectations of a robust Quality Management System and documentation.
Benefits of this role include:
- Opportunity to partner with internal and external stakeholders across teams.
- Understanding of applicable manufacturing/testing processes.
- Proven experience in designing and/or improving processes at conceptual level.
