**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.
The Specialist Quality Assurance will lead the implementation of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.
This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); resolve and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.
Primary Role: 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: Scheduling and performing evaluations of the 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 Trace Matrixes
+ 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 Integrity Assessments
+ 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
+ Qualitative information
+ Quantitative research
+ Trend data
+ 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.
Doctorate **OR** Master’s degree and 3 years of quality experience **OR** Bachelor’s degree and 5 years of quality experience **OR** Associates’ degree and 10 years of quality experience **OR** High School Diploma/ GED and 12 years of quality experience
+ 5+ years in supplier management and audit in a regulated industry (Medical, Pharma, Aerospace)
+ 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 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.
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.