Quality Assurance Specialist- QA for QC and Disposition

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Quality Assurance Specialist- QA for QC and Disposition

What you will do

Lets do this. Lets change the world. In this vital role you will implement the systems and capabilities required for disposition and for quality oversight of Quality Control activities, and then execute those processes as operations commence. This position requires analytical thinking skills to ensure compliance and quality with GMP regulations for all operations and associated processes.

• Provide Quality Oversight, assistance, and guidance of the QC Laboratories for issues such as non-conformance investigations, change control proposals, instrument qualifications, and lifecycle activities.
• Disposition product and raw materials while ensuring compliance with Quality policies and procedures, cGMPs, SOPs and Amgen standards.
• Provide quality expertise and guidance and work with cross-functional partners to achieve standard lead time targets for disposition of raw materials and product.
• Own and/or approve quality records including deviations/CAPAs and change controls assuring adherence to procedural requirements and confirming assessments and evaluations of different collaborators are complete and accurate.
• Own and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and FORMs.
• Interact with Supplier (Quality) Management teams and Suppliers for advanced cases of deviations or any other material supply related issues.
• Provide support during GMP Quality audits & inspections.
• Evaluate compliance issues, provide recommendations to Quality Leadership.
• Support Lean Transformation and Operational Excellence initiatives.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality Operations or Laboratory experience OR
• Associates degree and 8 years of Quality Operations or Laboratory experience OR
• Bachelors degree and 4 years of Quality Operations or Laboratory experience OR
• Masters degree and 2 years of Quality Operations or Laboratory experience OR
• Doctorate degree

Preferred Qualifications:

• Educational background in a science field
• Excellent written and verbal communication skills, ability to work in a team matrix environment and establish relationships with partners
• Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
• Knowledge of operations business processes, materials management, laboratory specifications and methods
• Ability in problem solving and experience in leading 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
• Proficiency with Document Control, Change Control, Exceptions Management, and Laboratory Management Systems
• Previous disposition experience supporting raw materials and/or product

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.