Specialist QA, Distribution and Supply Chain Quality Assurance – Amgen – Thousand Oaks, CA, USA
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
Provide Quality Assurance oversight for global distribution and supply chain operations for commercial and clinical biopharmaceutical products.
Ensure 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.
Key responsibilities include:
Internal Quality Assurance support for GMP warehouse and inventory management operations
External Quality Assurance support for Logistics Service Provider problem reports, temperature excursions, facility changes, audit reports, etc.
Internal Quality Assurance support for Distribution functions in establishment and maintenance of specific product transportation lanes and modalities, including shipper qualification and management
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
Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival
Master’s degree & 3 years of GMP or Quality experience
Bachelor’s degree & 5 years of GMP or Quality experience
Associate’s degree & 10 years of GMP or Quality experience
High school diploma / GED & 12 years of GMP or Quality experience
3+ years of experience in a Quality Assurance role supporting GMP operations
Previous experience with quality system transactions (SAP, SM-LIMS, Trackwise or Documentum)
Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent
Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training and adhering to good documentation practices
Educated in a science field with 5+ years of experience in GMP/GCP operations or similarly regulated industry
Proficient with database use, including data input, archival, and query retrieval
Great attention to detail and high degree of accuracy in task execution and GMP documentation
Highly effective verbal and written communication skills, strong interpersonal skills
Ability to complete tasks autonomously, provide updates to area manager and identify potential issues