Q. Where do you currently work?
A. I currently work at Amgen in Thousand Oaks, California, in External Supplier Quality Management
Q. What is your role at Amgen?
A. My role is a global centralized role within operations. I am responsible for the quality aspects of suppliers that provide raw material necessary for Amgen manufacturing globally to produce vital medicines for patients worldwide. My position supports Amgen operations in California, Colorado, Puerto Rico, Rhode Island, the Netherlands and contract operations worldwide. My primary responsibilities include oversight of all activities within Amgen's quality system associated with the supplier such as nonconformance investigations, CAPA records, change control records, supplier and material status within Amgen's SAP system. I also participate and lead cross functional teams with colleagues from Supply Chain, Process Development, Global Strategic Sourcing and other departments to assess, communicate and manage supplier performance via scorecards and business meetings and shape the business strategies pertinent to the supplier and/or the materials they provide. I also lead or participate in continuous improvement activities internally to eliminate waste and achieve standards of operational excellence for Amgen, and also manage the quality agreements associated with my suppliers.
Q. What is a typical day like for you on the job?
A. I work with the Amgen sites listed above to address raw material issues and concerns. Sometimes I will lead meetings between my company and the supplier and their quality groups/representative to partner together to determine root cause for raw materials issues. I manage change control records that we receive from suppliers. I work with Process Development, Incoming QA, Site Supply Chain and Quality Control groups to ensure their assessments have been completed for the change record and are acceptable to ensure there is no impact as a result of the supplier change. I also work on supplier investigations and resolving supplier issues, and manage the supplier audit program (evaluate cycle times and metrics for improvement opportunities; overseeing and participating in supplier audits, working with the supplier post-audit to ensure improvements or corrective actions are addressed to Amgen's requirements).
Q. What skills are necessary to be successful in your job?
A. Supplier relational management experience and supplier audit knowledge and background. Understanding of GMP and international regulations and requirements.
Q. What do you like most about what you do?
A. I have varying types of job duties, so I never get bored. I like working with different cross functional groups and teams to resolve issues or lead continuous improvement projects.
Q. Where have you worked before?
A. I have worked in similar GMP biotech/pharmaceutical environments including Contract lab testing, startup facilities, and pharmaceutical companies.
Q. Why did you choose to go into QA?
A. Understanding the methods and techniques required for implementing quality process and turning those methods into actions and building quality into the process/material can be challenging and fulfilling for me.
Q. What is your educational background?
A. Bachelor Science, Medical Microbiology, Cal State Long Beach
Q. What are your near-term and long-term career goals?
A. Near-term: I would like to learn as much as I can in Supplier Quality before I start looking into something else. There are so many things to learn still and I have been in this group for 4 years now. I am happy where I am currently. Long-term: Possible regulatory position, contract manufacturing quality or internal auditing of our functional groups.
Q. What advice would you give to students and professionals currently in the life sciences industry considering a career in QA?
A. People are the main force behind the success of quality. Drive towards continuous improvements, learn from best practices and eliminate non-value added work, learn Six Sigma principals, concepts and other quality tools. Join a professional organization such as ASQ and obtain certification. Also, enhance your knowledge in Quality - this will help you professionally and personally improve. Quality is not only for the workplace.
Field: Quality Assurance
Job: Quality Assurance Specialist
Company: Amgen
