Drug Product Quality Assurance Specialist

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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.

** Drug Product Quality Assurance Specialist*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role within the Plant Quality Assurance organization the Drug Product QA Specialist provides Quality oversight to operational activities associated with the aseptic Drug Product manufacturing and Inspection areas at Amgen, Thousand Oaks.

Under minimal supervision, the role ensures adherence to cGMP requirements, quality systems, and regulatory expectations while partnering closely with Manufacturing, Facilities & Engineering, and other cross-functional teams to support safe, compliant, and reliable operations.  Primary responsibilities for this role include ensuring timely delivery and completion of records within our Quality Management System, including Deviations, Corrective Actions and Preventive Actions (CAPAs), Change Controls and document revision, review and approval.  

The QA Specialist partners closely with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders to ensure events are thoroughly investigated, appropriately documented, and resolved in accordance with regulatory requirements and site procedures.

The Quality Specialist will also evaluate compliance and operational issues, provide recommendations and oversight, and ensure the progress of quality records to completion. The individual will 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:*
* + Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders to facilitate root cause analyses, risk assessments, CAPAs, and effectiveness verification activities.

+ Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.

+ 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.

+ Provides Quality Oversight of the manufacturing facility including manufacturing operations, inspection and utilities, as well as nonroutine activities such as process and product validation.

+ 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.

+ Contributes to and drives continuous improvement projects in cross-functional collaboration. Represents the Quality function and provides quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.

+ Contributes to and drives digital innovation solutions and applications in cross-functional collaboration.

** What we expect of you*
* We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

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* Basic Qualifications:

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* + Doctorate degree OR

+ Master's degree and 2 years of quality experience OR

+ Bachelor's degree and 4 years of quality experience OR

+ Associate's degree and 8 years of quality experience OR

+ High school diploma / GED and 10 years of quality experience

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* Preferred Qualifications:

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* + Bachelor's Degree in Science

+ 5 plus years of aseptic processing experience in QA or Manufacturing

+ Strong experience…