Specialist Quality Assurance Drug Product - Thousand Oaks CA

Specialist Quality Assurance - Drug Product

In this vital role, you will support the Plant Quality Assurance program providing daily oversight of operational activities associated with and supporting the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Duties include ensuring timely delivery and completion of records within our QMS, i.e. Deviations, CAPAs, Change Controls etc. SOP revision, review and approval, work order approval. The Specialist will also support tech transfers into the facility, evaluate compliance issues, provide recommendations, and assure progress of quality records to completion. The individual will also represent the B20 Quality function of projects necessary to achieve departmental and plant goals and will work in a dynamic cross functional environment.

Responsibilities:

• Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
• Provide Quality support to Tech Transfers into the Drug Product facility.
• Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
• Perform impact assessments as part of change controls impacting production or QA processes.
• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.
• Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports.
• Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Contribute to and drive continuous improvement projects in cross-functional collaboration.
• Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
• Supports or leads Inspection Readiness for the facility. Participates in internal/external audits and inspections and may directly interact with regulatory agencies during on-site inspections.