Amgen Senior Associate Quality Assurance in West Greenwich, Rhode Island
This role will assume the responsibility for supporting Quality System related deliverables for the External Quality Organization in support of Amgen's network of Contract Manufacturers, Contract Labs and Suppliers. This individual will be working with cross-functional teams that includes members from Amgen Contract Manufacturing Operations, Supplier Quality Management, Process Development, and Supply Chain
Responsible to train, manage and perform the following QMS related activities for External Quality Suppliers & Contractors:
Change Control including SCN's (Supplier Change Notifications)
Data Entry related tasks
Project team participation in support of day-to-day responsibilities
Own and revise procedures
Work cross functionally with ACM organization to execute to day-to-day responsibilities within QMS related systems. Support key deliverables and/ or projects as part of External Quality. Assure progress against commitments to regulatory agencies, identify compliance gaps and update all relevant procedures
Masters Degree OR
Bachelor's Degree & 2 years of Quality experience OR
Associate's degree & 6 years of Quality experience OR
High school diploma/GED & 8 years of Quality experience
5+ years biotech, pharmaceutical industry
Proficiency with electronic systems LIMS, TrackWise in supporting Nonconformance investigations, CAPA, Change Control, Complaints etc.
Demonstrated experience participating in, managing, and responding to QMS related tasks and responsibilities
Good understanding of cGMP requirements for Product Disposition, Investigations, CAPA, and Change Control
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships
Application of project management principles and techniques
Good understanding of cGMP and other applicable regulatory requirements.
Demonstrates ability with project management, including initiating and leading teams
Demonstrates ability to be flexible and adaptable to support business needs
Excellent conceptual problem solving/strategy skills, pragmatically define scope, and manage execution
Strong knowledge of the Biotech industry and QMS related processes involved in API, DS and DP manufacturing and distribution, QA, analytical laboratory, and validation.
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.