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)

Photo Library

NC's

CAPA

Complaints

Lims

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

Basic Qualifications:

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

Preferred Qualifications:

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.