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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Specialist QA Raw Material Disposition - Administrative Shift

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will be responsible for Disposition of Raw Materials, Floor support, Deviation Management and Quality Oversight. This team is a centralized team supporting AR5, AR30 and Warehouse. This position provides the opportunity to work directly with Supply Chain, Shipping, External Supply and Procurement for incoming raw materials. As a Specialist you will also facilitate real-time decision-making regarding quality requirements and deviations. Amgen’s Raw Material Disposition provides coaching, mentorship, and direction to Supply Chain, Warehouse, Manufacturing, Procurement, and our PQA Partners supervising Manufacturing Operations. This is an onsite position.

Responsibilities include the following:

• Ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
• Provide Quality Oversight to the Warehouse Floor operations including sampling, Dock operations, shipping, and Incoming/Receiving of Raw Materials.
• Ensures Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensures that facilities, equipment, materials, organization, processes, procedures, and products align with cGMP practices.
• Performs review and approval of cGMP processes, procedures, documents, and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations, Raw Materials and Drug Substance documentation.
• Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, and protocols/reports.
• Establishes and enables LEAN practices. Drives Operational improvement initiatives, programs, and projects.
• Coordinates and provides guidance of the Raw Material Reject Cage.
• Ensures that changes that could potentially impact product quality are assessed according to procedures.
• Ensures that deviations from established procedures are investigated and documented per procedures.
• Ensures that raw material batch packets and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alerts senior management of quality, compliance, supply, and safety risks.
• Completes required assigned training to permit execution of required tasks.
• Drive operational improvement initiatives, programs, and projects.
• Support Audits and Inspections

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications

• Doctorate degree Or
• Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience Or
• Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience Or
• Associate degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience Or
• High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience

Preferred Qualifications

• Experience and training in Trackwise, CDOCS, Maximo, LIMS, SAP
• Experience in leading multiple, opposing priorities in a fast-paced environment
• Strong cGMP and GDP behaviors
• Previous QA oversight of manufacturing or raw material warehouse
• Shown strength of written and verbal communication skills (including technical writing and presentations) with ability to optimally communicate and collaborate with technical and senior management staff. Experience in Raw Material or External Supplier Quality
• Experience in deviations, investigations, change controls, and CAPAs processes system knowledge
• Ability to tackle problems and make scientific risk-based decisions
• Ability to evaluate compliance issues and interact with regulatory inspectors
• Demonstrated proficiency using Excel, Word, Power Point, Smartsheet and Teams
• Strong organizational skills and ability to handle multiple tasks at one time
• Direct bulk drug substance and drug product experience

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

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