Specialist QA – Amgen – Thousand Oaks, CA, USA
The Specialist QA will provide Quality Assurance (QA) oversight for global distribution and supply chain operations for commercial and clinical biopharmaceutical products. Assure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution, inventory management, and management of external relationships with Logistics Service Providers like storage depots and transportation service providers.
Additionally, provide oversight and document/labeling approval support to the Thousand Oaks (ATO) Artwork Center and Global Text and Artwork Generation (GTAG) Team and represent ATO QA in the GTAG network.
Internal QA support for the following:
- GMP warehouse and inventory management operations and creation and revision of GMP procedures and record generation, including document review, approval, and archival
- Distribution functions in establishment and maintenance of specific product transportation lanes and modalities, including shipper qualification and management
External QA support for Logistics Service Provider problem reports, temperature excursions, facility changes, audit reports, etc.
Support investigations/deviation reports (Clinical Temperature Excursion Tracking System and Nonconformance). Assess incoming product lots for compliance to cold chain temperature requirements
Manage QA product reserve sample inventory. Compile and report process performance metrics
Review and approval for Amgen commercial labeling artwork and any related SOPs and associated Forms
Identify and resolve short- and long-term labeling-related issues across functions/sites
Serve as the primary Quality point of contact for artwork generated by the ATO Artwork Center and participate in all applicable site and network GTAG or Labeling change control meetings
Participate in cross-functional project teams for process improvements (i.e. Process Excellence, Metrics, and Regional Alignment meetings)
Master’s degree and 3 years of GMP or Label Artwork Management experience
Bachelor’s degree and 5 years of GMP or Label Artwork Management experience
Associate’s degree and 10 years of GMP or Label Artwork Management experience
High School diploma / GED and 12 years of GMP or Label Artwork Management experience
- 3+ years of experience in a QA role supporting GMP operations
- Great attention to detail and high degree of accuracy in task execution and GMP documentation
- Previous experience with quality system transactions (SAP, SM-LIMS, Trackwise, Documentum)
- Experience executing high priority process improvement initiatives
- Ability to lead, facilitate, influence and negotiate. Strong project management and presentation skills.
- Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues
- Experience handling multiple tasks and projects simultaneously including shifting priorities
- Strong knowledge of Quality Management System processes and/or manufacturing processes
- Able to work independently and effectively interact with various levels of staff and management
- Technical writing skills, demonstrated experience creating deviation technical assessments or equivalent
- Skilled in data analysis and trending of data using pivot tables and Cognos
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.