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Qa Specialist (32900) - 1828178

🌟 Job Opportunity: Quality Assurance Specialist 32900 (Drug Substance) 🌐

📍 Location: Juncos, PR (Onshore, 100% Onsite work with administrative shifts) 🌅

👩‍🎓👨‍🎓 Educational/Software Requirements:

  • Doctorate degree or Master's degree and 3 years of directly related experience
  • OR Bachelor's degree and 5 years of directly related experience
  • OR Associate's degree and 10 years of directly related experience 🎓💼
  • Preferred Qualifications: Experience in batch record review, DAI process, and familiarity with PASx/MES application, MAXIMO, SAP, and LIMS. 💻📊

🔍 Description:

As a Quality Assurance Specialist, you will perform essential duties under minimal supervision, supporting Amgen's Quality Assurance program. This includes reviewing and approving product Master Production Records (MPs), validating protocols and reports for manufacturing processes, participating in incident triage teams, approving Environmental Characterization reports, releasing sanitary utility systems, and more. 🚀📑🔧

🚀 Competencies/Skills:

  • Project management skills 📊
  • Strong organizational skills, including the ability to follow assignments through to completion 🔄
  • Initiate and lead cross-functional teams 🌐
  • Enhanced skills in leading, influencing, and negotiating 🤝
  • Strong knowledge in the area of expertise 🧠
  • Collaborate and coordinate with higher-level outside resources 🌍
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development 🌐💼
  • Demonstrate the ability to interact with regulatory agencies 🤝
  • Strong word processing, presentation, database, and spreadsheet application skills 💻📊
  • Strong communication (both written and oral), facilitation, and presentation skills 🗣️📢
  • Strong skills in working independently and effectively interacting with various levels 🤹
  • Advanced data trending and evaluation 📈
  • Ability to evaluate compliance issues ⚖️
  • Demonstrate the Amgen Values/Leadership Practices 🌐💼

🌈 Additional Requirements:

  • Availability for non-standard shifts, including nights and weekends. 🌙📅
  • Experience in batch record review, DAI process, and familiarity with PASx/MES application, MAXIMO, SAP, and LIMS. 📑🔧

🚀 Join us in Shaping the Future of Quality Assurance in Drug Substance Manufacturing! 🌟

Apply now and be part of a team dedicated to excellence and innovation. 🚀🌟

Thank you. We will be in contact soon.

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