Amgen

Incoming Quality Manager

Employer
Amgen
Location
New Albany, OH
Posted
Oct 06, 2021
Ref
R-129842
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time

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.

Manager, Incoming Quality: New Albany, Ohio

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be the lead for all Incoming Quality activities. A key aspect of this role is to apply sophisticated thinking to ensure quality and compliance to GMP regulations for all IQA (Incoming Quality Assurance) operations.

The Manager IQA will play a key role in the Quality Assurance team, focused on establishing the Incoming Quality Area and building a strong IQA team. This is the warehouse area, owned by the QA team, where all materials needed for the manufacturing of the finished drug product are sampled, inspected and dispositioned before being used in any GMP operation. Your team will work closely with the supply chain planning organization and supplier quality management to ensure timely dispositioning of the materials that are required for finished drug product manufacturing at the facility.

S/he will support all activities for the set-up of the new IQA area, administer timely commissioning/qualification of lab equipment/instruments and oversee successful execution of the method transfers through the use of lean principles. They will build an impactful IQA team as well as implement the Amgen Quality Management system (QMS) within the incoming QA area (e.g., Standard Operating Procedures (SOPs) creation, deviation management, change control, CAPA etc.).

  • Own the realization of all operational testing activities for IQA while providing technical expertise/guidance to the staff and ensuring materials are dispositioned in a timely manner; handle daily operations in relation to planning and management of materials, instruments, equipment and their team.

  • Provide oversight of the QMS process implementation applied in the IQA environment, including Deviation management, CAPAs, work-orders and change controls.

  • Interact with Supplier (Quality) Management teams and Suppliers for escalated cases of deviations or any other material supply related issues.

  • Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.

  • Own and review related SOPs, Methods, protocols and reports. Provide training and oversight for support staff.

  • Support and represent IQA 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. Drive Lean Transformation and Operational Excellence initiatives

Win

What we expect of you

Doctorate degree

OR

Masters degree and 3 years of Quality, Operations or Process Development experience

OR

Bachelors degree and 5 years of Quality, Operations or Process Development experience

OR

Associates 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

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

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 environment

  • Familiarity with the method transfer process and equipment commissioning and qualification activities

  • Affinity with digital innovation and data sciences

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

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

  • Strong organizational skills, including ability to follow assignments through to completion

ThriveSome 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

Apply now

for a career that defies imagination

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

careers.amgen.com


Join Us

If 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.