Drug Product Quality Assurance Specialist

Drug Product Quality Assurance Specialist

At Amgen, we are committed to serving patients with serious illnesses by developing, manufacturing, and delivering innovative medicines. In the Thousand Oaks plant, the Drug Product QA Specialist provides quality oversight for aseptic drug product manufacturing and inspection areas.

Under minimal supervision, you will ensure adherence to cGMP requirements, quality systems, and regulatory expectations while partnering with manufacturing, facilities, engineering, and quality control.

• 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 non‑routine 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.

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

• Doctorate degree OR
• Masters degree and 2 years of quality experience OR
• Bachelors degree and 4 years of quality experience OR
• Associates degree and 8 years of quality experience OR
• High school diploma / GED and 10 years of quality experience

• Bachelors degree in science
• 5 plus years of aseptic processing experience in QA or manufacturing
• Strong experience supporting deviation investigations, root cause analysis, CAPA development, and quality management system processes such as change control and risk management
• Knowledge of contamination control strategies, environmental monitoring programs, and utility monitoring systems within GMP manufacturing environments
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners at all levels within the organization
• Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality‑minded conclusions
• Experience applying problem‑solving tools for root cause analysis.
• Experience participating in, managing, and responding to corporate audits/regulatory inspections
• Demonstrated ability with project management, initiating and leading cross‑functional teams, leading and managing change

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills,…