Drug Product Quality Assurance Specialist
Amgen
Summary
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.
Job description
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.
Basic Qualifications
- 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
Preferred Qualifications
- 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
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
- 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
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Time-off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.