Quality Assurance - Technical Operations Specialist

Amgen • New Albany, OH

237d • $109,307 - $129,509 • 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 and/or Manufacturing experience.
• Bachelor's degree and 4 years of Quality and/or Manufacturing experience.
• Associate's degree and 8 years of Quality and/or Manufacturing experience.
• High school diploma / GED and 10 years of Quality and/or Manufacturing experience.

Nice To Haves

• Master's or Bachelor's Degree in Science.
• Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry.
• Affinity with digital innovation, data sciences and Quality engineering.
• Experience in review/approval validation documentation.
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
• Ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Experience working with dynamic cross-functional teams and abilities in decision making.
• Strong organizational skills, including ability to follow assignments through to completion.
• Strong leadership capabilities and experience applying GMP requirements in an operational setting.
• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

Responsibilities

• Oversight on daily manufacturing operations.
• Development and approval of standard operating procedures.
• Quality approval of deviations and final batch disposition.
• Evaluation of compliance and quality issues, providing recommendations for improvement projects.
• Assuring progress of records to completion.
• Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Electronic Master Batch Records.
• Provide quality oversight for quality records including deviations/CAPAs, technical change controls and work orders.
• Ensure that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements.
• Own quality related Standard Operating Procedures, Work Instructions, Forms and Methods.
• Provide quality oversight for manufacturing and be responsible for batch disposition.
• Provide quality and compliance expertise & guidance related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment and information systems.
• Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Support Lean Transformation and Operational Excellence initiatives.

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, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree