Drug Product Quality Assurance Specialist

About the role

The Drug Product Quality Assurance 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.

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.

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 preferred
• 5 plus years of aseptic processing experience in QA or Manufacturing preferred
• Strong experience supporting deviation investigations, root cause analysis, CAPA development, and Quality Management System processes such as Change Control and Risk Management preferred
• Knowledge of contamination control strategies, environmental monitoring programs, and utility monitoring systems within GMP manufacturing environments preferred
• 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 preferred
• Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions preferred
• Experience applying problem solving tools for root cause analysis preferred
• Experience participating in, managing, and responding to corporate audits/regulatory inspections preferred
• Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change preferred