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Associate Manufacturing Nights

Amgen
Full-time
Remote friendly (West Greenwich, RI)
United States

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Role Summary

Associate Manufacturing Nights

Responsibilities

  • Perform and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
  • Perform basic troubleshooting and assist in the review of documentation for assigned functions.
  • Participate on cross-functional teams and represent Manufacturing.
  • May also have the responsibility of owning NC/CAPA’s.
  • May identify, recommend, and implement improvements related to routine functions.

Qualifications

  • Basic Qualifications:
    • High school/GED + 2 years of manufacturing or operations work experience OR
    • Associate’s + 6 months of manufacturing or operations work experience OR
    • Bachelor’s degree
  • Preferred Qualifications:
    • Knowledge of single-use Bio-manufacturing technology
    • CFR and Regulatory knowledge
    • Mechanical ability/expertise
    • Knowledge of lab equipment and computers
    • Basic statistical mathematical skills
    • Ability to interpret and apply GMP knowledge
    • Understanding of analytical methods for manufacturing area
    • Ability to demonstrate technical writing capability
    • Able to demonstrate project management skills and presentation skills
    • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
    • Basic troubleshooting skills
    • Experience with Delta V, RD’s
    • Experience with lab equipment/testing

Skills

  • Manufacturing operations
  • Documentation and technical writing
  • Troubleshooting
  • Cross-functional collaboration
  • Process validation

Education

  • High school diploma or equivalent; Associate’s or Bachelor’s degree as alternatives in Basic Qualifications