Amgen Specialist QA in West Greenwich, Rhode Island
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.
What you will do
Let’s do this! Let’s change the world! In this vital role, you will be responsible for PQA Off the Floor support and activities. This team is a centralized team supporting two manufacturing facilities (AR5 and AR30), as well as the entire Amgen Rhode Island site. The team provides coaching, mentorship, and guidance to Manufacturing, Quality Control, Process Development, Supply Chain, Facilities & Engineering and IS staff regarding quality systems processes and compliance. Responsibilities include the following: Provide Quality oversight to Major Deviations, Change Controls, CAPAs/EVs, New Product Introductions (NPIs), Product Re-Introductions (PRIs) and Master Batch Records (MBRs) to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Additionally, this individual will be responsible for:
Ensuring that changes that could potentially impact product quality are assessed according to procedures
Ensuring that Facilities, Equipment, Materials, Manufacturing processes, Procedures and Products align with cGMP practices as well as other relevant regulations
Delivering Quality guidance to Document Management Systems records (CDOCs and GDMS)
Establishing and enable LEAN practices
Driving operational improvement initiatives and projects
Supporting Audits and Inspections
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is a strong communicator with these qualifications.
Doctorate degree OR
Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Experience in QA oversight of manufacturing, analytical and engineering activities
Experience in investigations, change controls, and CAPAs processes system knowledge
Ability to evaluate compliance issues and interact with regulatory inspectors
Experience and training in Trackwise, CDOCS, Maximo, LIMS
Experience in managing multiple, competing priorities in a fast-paced environment
Direct bulk drug substance and drug product experience Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to effectively communicate and collaborate with technical and senior management staff
Ability to problem solve and make scientific risk-based decisions
Demonstrated proficiency using Excel, Word, Power Point, Smartsheet and Teams
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
Objects in your future are closer than they appear. 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.