Aseptic Officer - Specialist QA

Amgen • Thousand Oaks, CA

104d • Hybrid

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.

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.
• Experience with leading or supporting an aseptic program for Drug Product operations.
• Excellent interpersonal, verbal and written communication skills with all levels within the Organization.
• Experience leading and directly coaching staff to drive improved performance and focus on operational excellence.
• 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

• Acts as the Quality organization's main point of contact and subject matter expert for all topics related to aseptic processing.
• Partners with colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain a strong culture of Quality and Safety.
• 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.
• 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 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.
• Contribute to and drive continuous improvement projects in cross-functional collaboration.
• Represent the Quality function and provide quality oversight during the implementation of projects.

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.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Industry: Chemical Manufacturing