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 Quality Control Live What you will do Does the thought of building an entirely new site, from the ground up excite you?
Do you love being an integral part of an impactful team?
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.
Job Summary Lets do this.
Lets change the world.
In this vital role you will work in a fast-paced Quality Control (QC) laboratory as a meticulous Senior Associate with Amgen Ohio (AOH).
This position will, under minimal supervision, implement U/HPLC, ELISA immunoassay, and Raman spectroscopy testing in in an electronic lab notebook (ELN) or on paper forms, as well as, in a laboratory information management system (LIMS).
They will ensure quality and operational excellence within the team and will be responsible for performing analytical testing/approval, equipment validation, method transfer/validation, and general troubleshooting all while providing technical expertise.
The Senior Associate may also be involved in procedures (Standard Operating Procedure, Work Instruction), deviations, out of specifications (OOS) and unexpected result (UR) investigations, and corrective and preventative actions (CAPA).
This position will work in a team environment, collaborating with various colleagues in the Amgen network while providing mentorship and acting as a training resource.
The environment is challenging, fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make meaningful improvements in the QC space.
Key Responsibilities: At all times, align with safety guidelines from EHSS, cGMPs, and other applicable regulatory requirements.
Plan and perform routine and non-routine analyses with efficiency and accuracy.
Report, evaluate, trend, and approve analytical data.
Troubleshoot, solve problems, and communicate with relevant team members.
Generate complete, accurate, and concise documentation using electronic systems and laboratory notebooks.
Participate in audits, initiatives, and projects that may be departmental or organizational.
Implement protocols and perform method transfer/validation and equipment qualification/verification.
Evaluate lab practices for compliance and operational excellence improvement (i.e., Lean & Six Sigma) on a continuous basis.
May lead/participate in lab investigations and support QC non-conformances as a subject matter expert.
May provide technical guidance for all QC related systems and methods.
May facilitate training in the QC environment.
May represent the QC department/organization on various teams.
May interact with outside resources from vendors to internal/external auditors.
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: Masters degree Or Bachelors degree and 2 years of Quality Control, Quality or Manufacturing experience Or Associates degree and 6 years of Quality Control, Quality or Manufacturing experience Or High school diploma / GED and 8 years of Quality Control, Quality or Manufacturing experience Preferred Qualifications: GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
Experience with bioassay (i.e., ELISA) analytical methods.
Experience using Waters H-Class UPLC and Agilent HPLC instrumentation.
Experience using Raman spectroscopy.
Experience using various QC systems such as CDOCS (Veeva Vault), TrackWise, Empower (CDS), LIMS and/or SmartLab (LMES).
Experience and knowledge of Data Integrity Requirements in QC systems.
Knowledge of statistical analysis tools used to perform data trending and evaluation.
Proficient in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).
Excellent problem-solving capabilities and attention to detail in delivering right first time results.
Experience of collaboration within and across functional areas.
Excellent written and verbal communication skills.
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.