Drug Substance Quality Assurance Specialist

Amgen • Thousand Oaks, CA

1d • $104,287 - $141,095

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. In this vital role within the Plant Quality Assurance organization, the Drug Substance QA Specialist provides quality oversight and compliance support for Drug Substance manufacturing operations at Amgen. Under minimal supervision, this 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. The Drug Substance QA Specialist will be a member of the Drug Substance Plant QA team and provide Quality oversight for Drug Substance Manufacturing and supporting Facilities & Engineering operations. Examples of Drug Substance manufacturing operations include Cell Bank, Cell Culture, and Purification. The individual will contribute to fostering a culture of Safety and Quality at Amgen Thousand Oaks. The QA Specialist provides Quality and Compliance oversight of GMP processes, procedures, investigations, and utilization of the Amgen Quality Management System. A primary responsibility of this role is providing Quality oversight and support for deviation management processes, including investigation review and approval, root cause analysis, corrective and preventive action (CAPA) development, effectiveness verification, and timely closure of quality records. 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. Responsibilities also include reviewing and approving GMP documentation, observing manufacturing operations, identifying and escalating quality risks, and providing guidance to operational staff to ensure compliance with established requirements and procedures. The individual proactively identifies and communicates quality, compliance, supply, and safety risks to management and works collaboratively with stakeholders to drive timely resolution.

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

• Excellent interpersonal skills
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
• Strong experience supporting deviation investigations, root cause analysis, CAPA development, and Quality Management System processes
• Knowledge of contamination control strategies, environmental monitoring programs, and utility monitoring systems within GMP manufacturing environments
• Experience supporting or partnering with microbiology laboratories, environmental monitoring programs, aseptic operations, or contamination investigations
• Direct experience driving process improvements.
• Working knowledge of Lean and Six Sigma methodologies a plus
• Experience participating in, managing, and responding to corporate audits/regulatory inspections
• Experience with Quality Management Systems, including Change Control, and Risk Management
• Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change
• Biology, Chemistry, or Engineering degree is desirable

Responsibilities

• Provides Quality oversight, review, and approval of major deviation investigations, ensuring events are thoroughly investigated, appropriately documented, and resolved in accordance with regulatory requirements and site procedures.
• Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders to facilitate root cause analyses, risk assessments, corrective and preventive actions (CAPAs), and effectiveness verification activities.
• Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements
• Observes GMP operations within a clean room environment and providing constructive feedback to staff and managers
• Reviews and provides Quality approval for GMP documentation such as revisions to procedures and GMP documents, investigation reports for major deviations, change control records, corrective action / preventive action records, and other GMP records
• Identifies and escalates significant quality, compliance, supply, and safety risks to management and supports risk-based decision making.
• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
• Participates as a QA team member process during regulatory inspections, third party audits, and internal audits
• Makes certain the Quality Management System processes are executed in accordance with established procedures
• May author and own cGMP documents and reports
• May also perform other duties as assigned

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: No Education Listed