top of page

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


SUMMARY:

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 🗣️


FUNCTIONS:

  • 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 🚚


COMPETENCIES/SKILLS:

  • 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 careers@proqualitynet.com 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.

bottom of page