Sr Specialist QA

Amgen (NASDAQ:AMGN), 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. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.

This position will entail supporting the product complaint system at Amgen. Responsibilities include; performing data trending and analysis to proactively detect signals and take appropriate action, providing corporate oversight to the process and sites, supporting corporate processes such as the Annual Product Review, Management Review complaint risk profiles, and representation on the product complaint network. Member of PQS Management team.

Interface with Senior management and business partners, data management and presentation, leading process improvement and operational excellence initiatives.

Other responsibilities may include: Supporting call intake and call center oversight, leading operational excellence efforts, management review of complaints, and interactions with regulators.

Doctorate degree and 2 years of directly related experience

OR

Master’s degree and 6 years of directly related experience

OR

Bachelor’s degree and 8 years of directly related experience

OR

Associate’s degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience

Preferred Qualifications:

Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience

General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
Strong knowledge of U.S. and International regulations and practices pertaining to product complaint and adverse event reporting.

Proven project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously. Excellent written and verbal communication skills, including facilitation and presentation skills.

Able to work in a team-oriented, matrix environment and independently interact with various levels of management to drive items to resolution. Demonstrated experience in interacting with regulators. Experience applying operational excellence principles and methodology.
Demonstrated experience achieving results and identifying areas of process design and improvement. Experience in investigations related to biologics, medical devices, and solid oral dose products

This position requires demonstration of strong leadership, negotiation and influencing skills along with advanced communication and analytical skills.

Understanding of biopharmaceutical bulk, drug product manufacturing and distribution processes.

To Apply:
As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace.
When you arrive at www.amgen.com/careers , please click on “Job Search” and then click on “Click Here to Search for Jobs”.
When the job search window appears, enter 13202BR in the “Search for” text box and then click on “Start Search”
When the position appears, select it, click on the “Apply” button and complete your application for the position

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=1417751-1789-1472