Aseptic Officer - Specialist QA - Thousand Oaks, CA

Aseptic Officer - Specialist QA - Thousand Oaks, CA

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist QA

What you will do:

Let's do this. Let's change the world. In this vital role within the Plant Quality Assurance organization the QA Specialist - Aseptic Officer, provides aseptic subject matter expertise and oversight to operational activities associated with the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under minimal supervision, the role provides compliance and aseptic 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 focused on aseptic operations, i.e. Deviations, CAPAs, Change Controls etc. document revision, review and approval, work order approval. The Aseptic Officer will also evaluate compliance and operational issues, provide recommendations, and assure progress of quality records to completion. The individual will also represent the B20 Quality function in projects as necessary to achieve departmental and plant goals and will work in a dynamic cross functional environment.

Responsibilities:

• Acts as the Quality organization's main point of contact and subject matter expert for all topics related to aseptic processing, such as during processing issues, or support for projects, the environmental monitoring program, deviation investigations, and validation.
• Partners 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 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.
• Participates in Amgen internal/external audits and inspections.
• Directly interacts with regulatory agencies during on-site inspections.
• 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.