QC Specialist

Role: QC Specialist supporting laboratory systems, primarily LIMS, within Amgen's Quality Control operations. Objectives include ensuring GMP compliance, data integrity, and CSV adherence across laboratory systems. Responsibilities encompass system lifecycle management (design, validation, implementation, maintenance), supporting laboratory operations (raw materials, testing, environmental monitoring), and driving continuous improvement. The role involves authoring SOPs, supporting audits and inspections, and collaborating cross-functionally with Manufacturing, Process Development, and IT. Qualifications: Doctorate or advanced degrees with relevant experience in quality systems, 5+ years in biotech/pharma QC or QA, familiarity with LIMS (preferably Sample Manager), and knowledge of GMP, 21 CFR Part 11, and Data Integrity. Preferred skills include supporting system implementations, system troubleshooting, data analytics, and familiarity with platforms like Empower, ELN, Veeva, or Kneat. The position requires strong technical writing, teamwork, and problem-solving abilities, with experience supporting regulatory inspections. The work environment is laboratory-based, supporting global harmonization of QC systems, with a focus on compliance and continuous process improvement.