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Associate Manufacturing-Nights

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

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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 the Inoc/Seeds group.
  • May be responsible for NC/CAPA’s and Change Control records.
  • 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
  • Preferred Qualifications:
    • Knowledge of small scale bioreactors, wave bioreactors, and aseptic processing.
    • CFR and Regulatory knowledge
    • Mechanical ability/expertise
    • Knowledge of WIP lab equipment and computers, with LIMS access
    • Basic statistical mathematical skills
    • Ability to interpret and apply GMP knowledge
    • Understanding of analytical methods for manufacturing area
    • Ability to demonstrate technical writing capability with Trackwise access
    • Able to demonstrate project management skills and presentation skills
    • Independently collaborate with outside resources
    • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
    • Basic troubleshooting skills on bioreactors
    • Experience with Delta V, RD’s
    • Experience with lab equipment/testing

Skills

  • Technical writing
  • GMP knowledge
  • Project management
  • Analytical and problem-solving skills
  • Cross-functional collaboration

Education

Additional Requirements

  • 12-hour rotating shift (7PM-7AM) with 15% shift differential and premium pay for Sundays; onboarding schedule may be 8am-5pm for 2-6 weeks.
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