QC Specialist - System Owner
This role must be located at the New Albany site near Columbus, Ohio.
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. 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 Amgens 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 Amgens plan to be a carbon-neutral company by 2027.
QC Specialist, System Owner: New Albany, Ohio
What you will do
Lets do this. Lets 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.
What we expect of you
Masters degree and 3 years of Quality, Operations or Process Development experience
Bachelors degree and 5 years of Quality, Operations or Process Development experience
Associates degree and 10 years of Quality, Operations or Process Development experience
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
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.