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Production Packaging Set Up Operator - 1st Shift

Company: Guerbet
Location: Raleigh
Posted on: January 15, 2022

Job Description:

The Packaging Operator's responsibilities include inspecting and packaging of terminally sterilized and aseptically produced pharmaceutical drugs in accordance with current Good Manufacturing Practices. This role is 2nd shift, Monday - Thursday 3 PM - 1:30 AM, with expected overtime.Position Responsibilities

  • Operate packaging equipment to package production within all applicable SOPS, cGMPs, etc.
  • Operate equipment within the validated parameters.
  • Perform 100% final inspection of units.
  • Label and package acceptable units.
  • Follow and maintain documentation records, accountability of solution and units throughout the production process.
  • Check and verify components.
  • Perform quality control duties, i.e. sampling of product and environment
  • Clean/sanitize production and warehouse areas and equipment
  • Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately
  • Special projects: training required for returned goods, reclaim and off-line projects.
  • Other duties as assigned with or without accommodation.Position RequirementsEducation required/ preferred:
    • High School diploma, GED, or equivalentExperience:
      • 1-3 years pharmaceutical manufacturing experience within a sterile environment (i.e. ISO 5E or similar)
      • Preferred Skills/Qualifications:
      • Ability to lift 50 pounds
      • Good math and reading skills
      • Mental and visual acuity for production of and identification of quality product

        • Good verbal and written communication skills
        • Ability to work both on a team and individually
        • Operator must understand and adhere to standard operating procedures (SOP's) in a pharmaceutical manufacturing environment and be able to apply Good Manufacturing Practices.
        • This position also requires successful completion of the training/certification program.
        • Responsible for reducing product losses and improving yields.
        • Responsible for quality of product.
        • Responsible for monitoring the process and documenting measurements per SOP.
        • Responsible for compliance with FDA, OSHA, cGMP's
        • Responsible for participation in all Safety aspects of the plant.
        • Responsible for demonstrating initiative, self-direction and ability to make decisions
        • Responsible for demonstrating and support of company policies

          Analytical Requirement:
          • Able to work flexible hours.
          • Requires high degree on manual dexterity, which could be performed under restrictive conditions.
          • Mental and visual accuracy is a demand to produce quality product.
          • Responsible for good verbal and interpersonal skills in communication.
          • Make sound decisions and have good math and reading skills.

Keywords: Guerbet, Raleigh , Production Packaging Set Up Operator - 1st Shift, Professions , Raleigh, North Carolina

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