Amgen

Senior Associate IQA

Employer
Amgen
Location
New Albany, OH
Posted
Apr 26, 2022
Ref
R-141066
Required Education
High School or equivalent
Position Type
Full time

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.

SENIOR ASSOCIATE IQA (INCOMING QUALITY)

The new Amgen Advanced Assembly and Final Product Operation facility in Ohio is seeking a Senior Associate Quality Assurance for the incoming Quality team. The role will provide quality oversight for the GMP receiving area and be responsible for execution of raw material inspection, sampling, and disposition activities. The Incoming Quality Area is the area in the warehouse (owned by the QA team) where all materials needed for manufacturing of the finished drug product are sampled, inspected, and dispositioned before being used in any GMP operation. The incoming Quality team works closely with the supply chain planning organization and supplier quality management to ensure timely dispositioning of the raw materials that are required for finished drug product manufacturing at the facility. The Sr. Associate IQA will also provide support in ensuring compliant implementation of the quality management system within the incoming quality area and the warehouse area. 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 sampling, inspection and dispositioning all raw materials received at the facility under general supervision. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include batch record review, SOP creation & review, documentation, review & approval of minor deviations and CAPA records and batch disposition of raw materials.

Responsibilities:
  • Implement raw material sampling and inspection activities, including completion of GMP documentation to support raw material disposition

  • Perform raw material disposition ensuring that all quality deliverables are met

  • Provide quality expertise & guidance and work with operations partners, supply chain and supplier quality management to resolve issues and ensure timely release of the raw materials

  • Own and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms

  • Own, investigate and approve quality records including deviations/CAPAs assuring adherence to procedural requirements and confirming assessments and evaluations of different collaborators are complete and accurate as needed

  • Find opportunities for continuous improvement and implement improvements in partnership with other operations teams

  • Provide support during GMP Quality audits & inspections

  • Support Lean Transformation and Operational Excellence initiatives

Win

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.

Basic Qualifications:

Masters degree

Or

Bachelors degree and 2 years of Quality and/or GMP Manufacturing experience

Or

Associates degree and 6 years of Quality and/or GMP Manufacturing experience

Or

High school diploma / GED and 8 years of Quality and/or GMP Manufacturing experience

Beyond that, additional preferred qualifications are:
  • Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies

  • Experience in and knowledge of GMP/GCP operations or similarly regulated industry

  • Affinity with digital innovation, data sciences and Quality engineering

  • Experience with raw material receipt, inspection & sampling

  • Highly effective verbal and written communication skills, strong interpersonal skills

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

  • Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

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

  • Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.

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 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.