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Qa Specialist 33124- 1873288

Title: Specialist QA 33124 🌟

Location: East of Puerto Rico 🌴

***Must be Resident of Puerto Rico***

Positions: 1️⃣

100% onsite work 🏢

Administrative shift 🕰️

Period: Approximately 1 year contract


Perform duties in support of Amgen's Quality Assurance program under minimal supervision. Educational background in Life Science and/or Engineering required.

Preferred Qualifications:

  • Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control) 📊
  • Hands-on experience in electronic systems: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES), and SAP 💻
  • Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols 📝
  • Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications 🌱
  • Enhanced skills in leading, influencing, and negotiating, with the ability to interact with regulatory agencies and evaluate compliance issues 💬
  • Fully Bilingual in English and Spanish 🗣️


  • Review and approve product MPs 📑
  • Approve process validation protocols and reports for manufacturing processes 📋
  • Request Quality on incident triage team 🔍
  • Approve Environmental Characterization reports 🌍
  • Release of sanitary utility systems 💧
  • Approve planned incidents ⚠️
  • Represent QA on NPI team 🚀
  • Lead investigations 🔍
  • Lead site audits 🔦
  • Own site quality program procedures 📜
  • Designee for QA manager on local CCRB 📊
  • Review Risk Assessments ⚖️
  • Support Automation activities 🤖
  • Support facilities and environmental programs 🏭
  • Review and approve Work Orders 📃
  • Review and approve EMS/BMS alarms 🚨
  • Approve NC investigations and CAPA records 📊
  • Approve change controls ✅
  • Provide lot disposition and authorize lots for shipment 🚚


  • Project management skills 📊
  • Strong organizational skills, including ability to follow assignments through to completion 📆
  • Initiate and lead cross-functional teams 🤝
  • Enhanced skills in leading, influencing, and negotiating 🌟
  • Strong knowledge in 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 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 skill in working independently and to effectively interact with various levels 🎯
  • Advanced data trending and evaluation 📊
  • Ability to evaluate compliance issues ⚖️
  • Demonstrate the Amgen Values/Leadership Practices 🌟

Send us your updated resume to with the title "Specialist QA 33124 Application" in the subject line. Don't miss out on this chance to be part of an innovative and dynamic team! 🚀

#CareerOpportunity #QAExpert

Thank you. We will be in contact soon.

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