Specialist Quality Assurance - Drug Product

Amgen • Thousand Oaks, CA

2d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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. Specialist Quality Assurance - Drug Product What you will do Let’s do this. Let’s change the world. In this vital role you will support the Plant Quality Assurance program providing daily oversight of operational activities associated with and supporting the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Duties include ensuring timely delivery and completion of records within our QMS, i.e. Deviations, CAPAs, Change Controls etc. SOP revision, review and approval, work order approval. The Specialist will also support tech transfers into the facility, evaluate compliance issues, provide recommendations, and assure progress of quality records to completion. The individual will also represent the B20 Quality function of projects 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
• Excellent interpersonal, verbal and written communication skills with 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.
• Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.
• Applies project management principles and techniques.

Responsibilities

• Partner 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.
• Provide Quality support to Tech Transfers into the Drug Product facility.
• Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
• Perform impact assessments as part of change controls impacting production or QA processes.
• 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.
• Contribute to and drive continuous improvement projects in cross-functional collaboration.
• Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
• Supports or leads Inspection Readiness for the facility.
• Participates in internal/external audits and inspections and may directly interact with regulatory agencies during on-site inspections

Benefits

• 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’ll support your journey every step of the way.
• 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