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Job

Assembler (4)

  • Job ref:

    11066

  • Location:

    Lowell, United States

  • Sector:

    Assemblers

  • Job type:

    Contract

  • Contact:

    Bob Giusti

  • Published:

    8 days ago

  • Consultant:

    Bob Giusti

Responsibilities:

  • Works in a safe manner and follows safety rules at all times.
  • Ability to problem solve and communicate issues/resolutions to production management.
  • Understands undertakes and implements quality control/assurance techniques and procedures.
  • Ability to work with minimal supervision, supports, and drives process improvements and team culture.
  • Follows procedures to ensure the production of a quality product.
  • Generates product labels to meet production demand.
  • Adhere to a production schedule and ensure that materials are stocked and ready for the production day.
  • Inspect and ensure that all equipment is calibrated and in working order; balances/scales, pipettes, mediaclave, water purification systems, etc.
  • Sanitization and autoclaving of all media production equipment and areas prior to and following production work.
  • Performs aseptic techniques while following the SOPs.
  • Documents lot numbers, calibration and serial numbers of all equipment used as well as any pre-fill QC; pH, temperature, water resistivity, TOC levels, etc.
  • Completes batch process records and ensure they are correct and complete.
  • Assist with the execution and documentation of IQ/OQ and PQ processes.
  • Maintain and post Manufacturing metrics.
  • Perform work that is compliant with cGMP, ISO, QMS and other pertinent regulations and directives.
  • Support immediate supervisor and peers by anticipating problems, providing input on solutions, reacting productively to change and handling other tasks as assigned.

Qualifications/Experience:

  • Experience with automated manufacturing processes is a plus.
  • Ability to perform simple maintenance and troubleshoot automated equipment a plus.
  • At least 1 year of cleanroom experience required.
  • Excellent aseptic process/laboratory skills.
  • Working knowledge of cGMP and ISO guidelines. Familiarity with FDA regulations a plus.