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Operations Sampling Technician I

Novo Nordisk
Full-time
On-site
Clayton, NC
Operations

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Role Summary

Operations Sampling Technician I at Novo Nordisk. Supports all daily activities of a cGMP warehouse operation including inspection, sampling, sample management, shelf-life expiry inventory, job instructions, and regulatory compliance.

Responsibilities

  • Package samples for transport
  • Follow Standard Operating Procedures in performance of assigned duties
  • Support GMP Laboratory and Environmental Compliance through daily tasks and ensure compliance with training programs related to job functions
  • Partner with QC, QA, EM & support groups to ensure raw material release for production and resources to support schedules and enable the process to run optimally
  • Maintain CNC areas and perform routine cleanings and batch turnover
  • Complete all paperwork in a cGMP compliant manner
  • Participate in Systematic Problem Solving, Lean Mindset, and streamlining processes
  • Support validation and project activities as required
  • Sampling of Raw Materials from Bulk tankers, Pressurized Containers, IBCs, drums and palletized material
  • Ensure all errors are addressed and corrected in real time ensuring compliance with cGMPs
  • Record logbook entries and other associated forms/paperwork for the team
  • Follow all safety and environmental requirements in the performance of duties
  • Other duties as assigned

Qualifications

  • High School Diploma or equivalent with a minimum of one year of experience operating in a GMP regulated environment required
  • Associateβ€šΓ„Γ΄s Degree in Science or relevant field of study from an accredited university preferred
  • BioWorks Certification preferred
  • Basic laboratory, sampling aseptic and ID testing techniques required
  • Ability to read, write and understand product documentation and standard operating procedures with attention to detail; computer literacy required
  • Knowledge of US, EU regulations and guidelines in reference to classified areas, sampling plans and methods and application of GMPs a plus
  • Ability to communicate technical information clearly in writing and presentations preferred
  • Demonstrated experience in practical problem solving and process improvements a plus
  • Experience in LIMS system a plus
  • Experience planning, organizing, executing, checking results and revising work plans a plus

Skills

  • Strong attention to detail
  • Effective written and verbal communication
  • Problem solving and process improvement mindset
  • Team collaboration and cross-functional coordination

Education

  • High School Diploma or equivalent; additional science-focused degree preferred

Additional Requirements

  • Physical requirements related to moving equipment up to 33 pounds, standing/walking, and potential exposure to hazardous materials as described