Drug Product Quality Assurance Specialist

Amgen • Thousand Oaks, CA

18h

About The Position

Join Amgen’s Mission of Serving Patients. 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. 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.

Requirements

• 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

Nice To Haves

• Bachelor’s 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

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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED