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Qa Specialist 33226- 1998221

Title: Specialist QA (Drug Substance) 33226 🌟


SUMMARY:

Join our dynamic team and contribute to Amgen's Quality Assurance program with minimal supervision. This role offers hybrid/virtual/remote work on an administrative shift basis for approximately one year.


Preferred Qualifications:

  • Educational background in Life Science and/or Engineering 📚
  • Trackwise system queries, deviations proficiency 🛠️
  • Participate in triage process 🔍
  • Oversight of process/procedures/GMP tasks 🧪
  • Manage Change Controls and deviations for QA approval 📋
  • Resolve basic compliance discrepancies with operations 🌐
  • Knowledge in Validations and Laboratory area/equipment 🧪
  • Strong organizational skills with task completion focus 📝
  • Leading, influencing, negotiating skills with regulatory agency interaction 🤝
  • Microsoft Office proficiency and bilingual in English and Spanish 📊🗣️
  • Strong communication (written/oral) and presentation skills 🗣️💼


FUNCTIONS:

  • Review and approve product MPs ✔️
  • Approve process validation protocols and reports ✔️
  • Request Quality on incident triage team ✔️
  • Approve Environmental Characterization reports ✔️
  • Release 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 ✔️


EDUCATION/LICENSES:

  • Doctorate/Master's degree with 3 years related experience
  • Bachelor's degree with 5 years related experience
  • Associate's degree with 10 years related experience
  • High school diploma/GED with 12 years related experience


COMPETENCIES/SKILLS:

  • Project management skills 📊
  • Organizational skills for task completion 📋
  • Lead cross-functional teams 🤝
  • Leading, influencing, negotiating skills 🌟
  • Knowledge in QA, QAL, validation, process development 🧪
  • Interact with regulatory agencies 🏛️
  • Microsoft Office proficiency 📊
  • Communication and presentation skills 🗣️💼
  • Work independently and interact effectively with all levels 🌟
  • Data trending and evaluation skills 📈
  • Evaluate compliance issues 📊
  • Demonstrate the Amgen Values/Leadership Practices 🌟


Join our dynamic team and take the next step in your career by sending us your updated resume today!

Thank you. We will be in contact soon.

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