Sr. Laboratory Operations Specialist

3 weeks ago


Skokie, United States The Steely Group Full time

Our client is seeking a highly skilled and motivated Operations Specialist to support their Operations team by implementing and executing manufacturing processes in a regulated, controlled environment.


You will have opportunities to participate in various projects and initiatives in addition to these


Primary Responsibilities:

  • Support the Operations team in drug substance and/or drug product manufacturing.
  • Help draft technical documentation for drug product manufacturing.
  • Assist the Operations team with environmental monitoring, cleaning programs, and inventory management.
  • Maintain manufacturing areas and process components to ensure a clean, safe and organized work environment.
  • Work collaboratively with and support the Development Lab and Quality teams.
  • Follow standard operation procedures (SOP) and work instructions to execute tasks.

Requirements / Qualifications:

  • Minimum of 5 years of experience working in manufacturing or laboratory operations required.
  • Ability to work in a clean room environment is required.
  • Pharmaceutical or Medical Device industry experience is preferred.
  • Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
  • Must be well organized, attentive to detail, and have effective verbal and written communication skills.
  • Must be able to efficiently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment.



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