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Amgen Taiwan5 days ago

QA Specialist

$104,287–$141,095 year

On-site · West Greenwich, Rhode Island, United States

Type
Full Time
Level
Mid Level
Education
Doctorate Or Professional Degree
Company size
Enterprise

Job Summary

QA Technical Services Specialist provides quality oversight for deviations, CAPA, and change controls; manages the change control process and approves GMP documents and records; serves as subject-matter expert for Deviation, CAPA, EV, Change Control and Quality Risk Management; collaborates with project teams to integrate quality considerations into planning and execution; independently assesses and prioritizes quality risks across functions; drives continuous improvement and maintains inspection readiness across the network; strong written and verbal communication skills to interact with cross-functional teams and management; role may involve enterprise risk management within GxP environments and alignment with regulatory and inspection readiness expectations.

Required Qualifications

  • High school diploma / GED with 10 years of Quality and/or Manufacturing experience
  • Associate’s degree with 8 years of Quality and/or Manufacturing experience
  • Bachelor’s degree with 4 years of Quality and/or Manufacturing experience
  • Master’s degree with 2 years of Quality and/or Manufacturing experience
  • Doctorate degree with related quality/manufacturing experience
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$104k – $141k / yr

QA Specialist · Amgen Taiwan

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