Career Category

Job Description

This role must be located at the New Albany site near Columbus, Ohio.

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.

Does the thought of building an entirely new site, from the ground up excite you? Do you love building and developing high performing teams? If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the facility will not only feature the best in-class assembly and packaging 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.

QC Specialist, System Owner: New Albany, Ohio

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will play a key role in the Quality Control team with a focus on equipment related activities and system ownership. You will lead and direct other QC and cross functional staff as an informed Subject Matter Expert (SME) in the Quality Control deliverables. The SME will apply sophisticated thinking to ensure quality and compliance to GMP regulations for all QC operations.

• Evaluate compliance issues, provide recommendations, and assure progress of records to completion.

• Build and lead implementation strategies related to the design, installation, commissioning & qualification of the QC laboratory equipment. Perform daily oversight for equipment related tasks to ensure scheduled work is performed as planned, this includes CMMS: job plan development, quotation requests, work order scheduling / completion and vendor coordination.

• Author, review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Work Instructions, etc.

• Responsible for Data Integrity Assessments, Security Assessments and periodic reviews of the equipment. Decide in conjunction with the Business Owner & Quality if controls are acceptable; implement mitigations as required and agreed between team members.

• Initiate, implement and track completion of quality records including deviations/CAPAs, technical change controls and work orders assuring adherence to procedural requirements and confirming assessments and evaluations of different partners are complete and accurate.

• Ensures that all activities and related documentation comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

• Provide training and oversight for support staff.

• Support and represent QC during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for equipment implementation. Support Lean Transformation and Operational Excellence initiatives.

Win

What we expect of you

Doctorate degree

OR

Master’s degree and 3 years of Quality, Operations or Process Development experience

OR

Bachelor’s degree and 5 years of Quality, Operations or Process Development experience

OR

Associate’s degree and 10 years of Quality, Operations or Process Development experience

OR

High school diploma / GED and 12 years of Quality, Operations or Process Development experience

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:

• Bachelor's degree in life science with 5+ years of experience in GMP controlled lab environment

• Affinity with digital innovation and data sciences

• IS validation knowledge

• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners

• Great attention to detail and high degree of accuracy in task completion and GMP documentation

• Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues

• Demonstrated ability in problem solving and experience in leading Root Cause Analysis / Deviation investigations

• Experience working with dynamic cross-functional teams and demonstrated 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

• Experience with CMMS, CDOCS, TrackWise

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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.

careers.amgen.com