This role requires local presence at the New Albany facility near Columbus, Ohio.
HOW MIGHT YOU DEFY IMAGINATION?
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 Advanced Assembly and Final Product Operation 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.
QUALITY ASSURANCE SPECIALIST
Reporting to the Senior Manager Quality, the QA specialist for the new Amgen Advanced Assembly and Final Product Operation facility will provide quality oversight support of the design, installation, commissioning & qualification and process qualification of the new facility and equipment. QA specialist will also support implementation of the Amgen Quality management system into the new facility. This can cover a wide range of quality processes that drive and govern operations in manufacturing, warehousing and quality assurance (e.g. deviation management, disposition, change control etc.).
This role will require local presence at the New Albany facility near Columbus, Ohio.Live
What you will do
Lets do this. Lets change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.
In this vital role you will be responsible for leading and directing cross functional staff as an informed Subject Matter Expert in the Quality deliverables under general supervision. A key aspect of this role is to utilize critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include validation documentation review & approval, SOP creation, review & approval, quality support in electronic batch record creation, quality approval of deviations & CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of records to completion.
Provides quality and compliance expertise & guidance and agrees on execution strategies related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment and information systems.
Reviews and approves controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Electronic Master Batch Records etc.
Provides quality oversight for quality records including deviations/CAPAs, technical change controls and work orders assuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate
Ensures that all activities & related documentation for facilities, equipment, materials and processes comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
Own quality related Standard Operating Procedures, Work Instructions, Forms and Methods
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
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.
Masters degree and 3 years of Quality and/or Manufacturing experience
Bachelors degree and 5 years of Quality and/or Manufacturing experience
Associates degree and 10 years of Quality and/or Manufacturing experience
High school diploma / GED and 12 years of Quality and/or Manufacturing experience
Bachelors 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
IS validation knowledge
Experience in review/approval validation documentation
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 execution and GMP documentation
Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
Experience working with dynamic cross-functional teams and proven abilities in decision making
Strong organizational skills, including ability to follow assignments through to completion
Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
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.