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Job Details


Amgen

Sr. Associate Plant QA

Pharmaceuticals

All

Full Time

On Site

No

New Albany, Ohio, United States

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 hard-working 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 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 Amgen’s plan to be a carbon-neutral company by 2027.

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.

Senior Associate Plant QA

The Sr. Associate Plant QA for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Quality Assurance Floor Support team providing QA oversight to GMP operations in the Device Assembly and Finished Product Packaging Area. The Sr. QA Associate will support multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by applying the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Production, IQA, and other groups, as needed. Advising Production on proper documentation as needed and performing other duties as assigned.

This role will require local presence at the New Albany facility near Columbus, Ohio.

Live

What you will do

Let’s do this! Let’s change the world!

  • Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.

  • Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.

  • Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.

  • Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.

  • Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place

  • Perform finished product checks during (commercial) production runs

  • Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.

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

  • Review and approve Deviation, CAPA, and Change Control records.

  • Participate in self-led inspections and provide support during internal / external regulatory inspections.

  • Support Lean Transformation and Operational Excellence initiatives

  • Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.

Basic Qualifications:

Master’s degree

Or

Bachelor’s degree and 2 years of Quality and/or GMP Manufacturing experience

Or

Associate’s 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

Preferred Qualifications:

  • 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 task execution and 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 improve 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.

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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.