As part of the Operations Performance Excellence (OPE) team, this position is responsible for the Standardized Root Cause Analysis (SRCA) program. The SRCA Program is a structured approach to identifying true root cause. It begins with the use of the 5-Why methodology and then progressively applies more sophisticated tools as necessary. The additional tools include Causal Factor Analysis, Kepner-Tregoe Analysis and general problem solving methods.
Leading/completing root cause analyses.
Leading/completing other high priority Operational Excellence (OE) efforts in Quality and serving as a member of the OE Network.
Own the training materials for root cause analysis and provide the training to Amgen staff members.
Apply the SRCA methodologies to identify true root cause(s) of operational failures.
Assist with the Lean Transformation of Amgen's Quality Control laboratories.
Serve as Corporate Quality's representative in the OE network.
25-30% travel to other Amgen locations and / or supplier.
Doctorate degree and 2 years of Science, Engineering or Project Management experience
Master's degree and 4 years of Science, Engineering or Project Management experience
Bachelor's degree and 6 years of Science, Engineering or Project Management experience
Associate's degree and 10 years of Science, Engineering or Project Management experience
High school diploma / GED and 12 years of Science, Engineering or Project Management experience
Master's degree in Science, Engineering, Industrial Engineering, Operations Research or MBA
5+ years' experience in pharmaceutical or biotechnology industries
5+ years' experience in Industrial Engineering, Operations Research and/or Operational Excellence related roles
In-depth knowledge of Continuous Improvement tools, techniques and methodologies (Six Sigma, Define, Measure, Analyze, Improve, Control (DMAIC) and/or Lean Manufacturing), as well as practical experience applying them to improve the performance of processes, people and systems
Lean Manufacturing and Lean Six Sigma experience
Strong leadership skills, communication skills (both verbal and written) and the ability to approach issues from a strategic perspective
Six Sigma Black Belt or Master Black Belt
2+ years' direct supervisory experience in a manufacturing or similar environment, to include (Current Good Manufacturing Practices (cGMP), Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA)
Proven project management skills and leadership and demonstrated ability to execute and manage complex projects and programs
Strong analytical skills, financial acumen and expertise in MS Office applications (MS Project)
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.