Specialist Quality Assurance (R-147608)
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.Live
What you will do
Let’s do this! Let’s change the world!
Quality resource to support the process for classifying, evaluating, approving, monitoring, and inactivating Computerized Systems GxP Suppliers. In this role you will help manage Amgen’s regulated computerized systems suppliers by: Schedule and lead supplier evaluations of regulated computer systems and support processes
Developing mitigation plans
Creating and maintaining quality agreements.
Participate as a GxP computerized systems SME in evaluating external regulated (GMP/GCP/GLP/GPvP) vendors for regulated R&D activities.
Ensure issues of significant compliance matters are advised to appropriate compliance/quality oversight bodies
Contribute to Continuous Improvement Initiatives
Some travel may be required (approx. 10% per month)
May be required to work on other Quality QMS documentation
Review and Approve Requirement Specifications, Design Specification, Testing Protocols,
Validation Plans, Summary Reports, and other validation documentation
Initiate and own QA Deviations (Major, Minor) as needed
Act as reviewer and approver for operational and administrative SOP’s and Work Instructions
Responsible for reviewing and approving Periodic Reviews, Change Controls and Data
Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
Forecasts, models and applies advanced analytical tools
Anticipates and prevents potential problems
May be responsible for specific programs and/or projects
Independently develops solutions that are thorough, practical and consistent with functional objective
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Master’s degree and 3 years of quality experience
Bachelor’s degree and 5 years of quality experience
Associates’ degree and 10 years of quality experience
High School Diploma/ GED and 12 years of quality experience
5+ years in supplier management and audit in a regulated industry (Medical, Pharma, Aerospace)Requirement 1
Ideal candidate would have 3-5 years leading supplier evaluations/audits in a regulated space.
5+ years experience in Computer System Validation
Technical degree in related subject
Expertise in 21 CFR part 11 and Annex 11, Solid understanding of Computer Systems validation, SDLC, Change Control, Data Integrity,
QMS and supportive computerized systems processes
General knowledge of clinical development and PV process and operations
Deep and broad understanding of quality processes including change control, risk assessment and management, etc.
Strong problem solving, trouble shooting, and analytical skills
Constructively progress to outcomes despite uncertainty or ambiguity
Excellent verbal and written communication
Experience owning and serving as QA Contact for Major and Minor Deviations
Technical knowledge of IS systems such as ServiceNow, LIMS, CDOCS, SAP, Maximo
Ability to interpret and apply GMP, GLPs, GCP’s and GMPs
Broad technical knowledge within own specialty area
Knowledge of industry and business principles
Demonstrated problem solving abilities
Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
Provides training and guidance to others
Extends capabilities by working closely with senior staff/ experts within and outside the internal organization
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.[Register to View]
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.