Specialist Product Complaint Trend Investigator

The Specialist Product Complaint Trend Investigator will be responsible for conducting and documenting product complaint trend investigations integral to the design, manufacture, and delivery of Amgen products. Trend investigations will be completed through the review of manufacturing batch records, evaluation of returned sample, product reserve sample inspections, and review of complaint histories and trends. Complaint owners will assign root cause analysis to the Final Product Technologies Product Complaints Investigation team. Complaint owners will help identify corrective actions after the identification of the root cause of a complaint. Complaint owners will track all product complaint investigations and assigned complaint event codes. Upon completion of these activities a final report will be prepared in accordance with established procedures.

Responsibilities:

• Understand customer / patient use of Amgen's packaged and/or distributed products
• Understand manufacturing processes for Amgen's packaged and/or distributed products
• Track receipt, investigation and closure of product complaints to ensure adherence to established timelines
• Investigate complaints and subsequently document the review, evaluation, investigation, actions taken, and corrective actions taken
• Assure regulatory compliance of the product complaint program is maintained
• Support operations and quality management initiatives and objectives
• Other responsibilities may include: performing deep dive data analysis, managing trending signal detection program and identifying appropriate corrective/preventative action
• Travel +/- 10% of time to domestic and international Amgen sites

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Quality or Manufacturing experience

OR

Bachelor's degree and 5 years of Quality or Manufacturing experience

OR

Associate's degree and 10 years of Quality or Manufacturing experience

OR

High school diploma / GED and 12 years of Quality or Manufacturing experience

Preferred Qualifications:

• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor's Degree in a Science Field
• Ability to oversee multiple projects simultaneously
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

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.

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.