Senior Associate Quality Control - HPLC (Drug Substance)
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.
Senior Associate Quality Control -- HPLC
What you will do
Let’s do this. Let’s change the world! In this vital role you will be responsible for one or more of the following activities in Quality Control including analytical testing, characterization, method development, sample and data management. This role will support irregular hours, rotating and night shifts that may include weekends and holidays.
Specific responsibilities include but are not limited to:
- Perform/review and approve routine laboratory procedures and analysis, ensuring complete, accurate, and concise documentation
- Report, evaluate, back-up/archive, trend and approve analytical data
- Provide training to team-members as well maintaining own training proficiency
- Perform or review one or more of the following: sample testing, standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance
- Perform general lab housekeeping
- Evaluate lab practices for compliance on a continuous basis
- Maintain/operate specialized equipment
- Initiate and/or implement changes in controlled documents and participate in the document revision process
- Align with safety guidelines, cGMPs and other applicable regulatory requirements
- Plan and perform multiple, sophisticated routine/ non-routine methods and procedures and a large variety of assays
- Troubleshoot, solve problems, and communicate with stakeholders
- Participate in audits, initiatives and projects that may be departmental or organizational in scope
- Write protocols and perform assay validation and equipment qualification/ verification
- Introduce new techniques to the lab, including method transfers, reports, validations, and protocols
- May perform aseptic aliquot ting, sampling and analysis for compendia and non-compendia methods, non-routine lab procedures under close supervision, provide technical guidance, contribute to regulatory filings, support laboratory investigations, interact with outside resources, and represent the department/organization on various teams aligned with operational objectives.
What we expect of you
We are all different! Yet we all use our outstanding contributions to serve patients. The Senior Associate Quality Control professional we seek is an individual contributor with these qualifications.
Bachelor’s degree and 2 years of quality or laboratory experience
Associate’s degree and 6 years of quality or laboratory experience
High school diploma / GED and 8 years of quality or laboratory experience
- Educational background in Chemistry and/or Bio-Chemistry
- Experience working with HPLC methodology, equipment, and associated software such as Empower
- Solid understanding and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development
- Demonstrate ability to interact with regulatory agencies and evaluate compliance issues.
- Strong word processing, presentation, database, and spreadsheet application skills
- Advance data trending and evaluation
- Strong communication (both written and oral), facilitation and presentation skills
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 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
for a career that defies imagination
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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.