13 Aug
Packaging and Labeling Technician
Connecticut, Usct 00000 Usct USA

Vacancy expired!

Job Description

This person will supportprinting and inspection of labels for application to clinical trial supplies. To package clinical trial supplies, utilizing packaging batch records and diagrams to primary pack solid dosage forms, and label them, prior to assembly into patient / treatment packs. Set up and operate packaging equipment, to bottle fill supplies working to current Good Manufacturing Practice guidelines.

  • Set up and operate equipment to bottle-fill or hand-fill solid dosage forms into primary containers.
  • Label finished dosage forms, e.g. pre-packs, vials, devices, etc and assemble into patient / treatment packs, whilst maintaining the blind of the study.
  • Engage with the Packaging Coordinators (PC) to develop practical and efficient packaging designs of Clinical Supplies to support studies.
  • Engage with PC to ensure the Packaging Diagram contains sufficient detail regarding the packaging to be completed.
  • Using modules within Clinicopia, fulfill Packaging Requests following the completion of primary and/or secondary packaging operations.
  • Accurately complete packaging documentation and internal paper work to support packaging operations.
  • Update the local planning schedule with the progress of work and immediately raise issues with the PC that may result in failure to meet timelines.
  • Work with Inventory Management and Quality Assurance to co-ordinate and drive the progress of the packaging operation to ensure timelines are met.
  • Carry out a completion review of packaging documentation before submission to a PC.
  • Using Clinicopia, print and inspect labels that have been designed and approved within the system.
  • Support the packaging of stability packaging requests.
  • Support internal GMP audits and self-inspections.
  • Keep current with all Good Manufacturing Practice training.
  • Work with EHS on safety related issues and support safety inspections, and work with Global Operations and Inventory Management to address any facility issues.

Qualifications

  • High School Diploma orequivalent
  • Experience in GMP environment
  • 2 years of relevant experience preferred
  • Experiencing handling, dispensing dosage forms in retail or hospital environment
  • Packaging experience in a GMP environment; thorough understanding of Good Manufacturing Processes (cGMP)
  • Computer literacy in Microsoft Word
  • Strong computer, scientific, and organizational skills
  • Excellent communication (oral and written) and attention to detail
  • Ability to work independently and as part of a team, self-motivated, adaptability, andapositive attitude
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

All your information will be kept confidential according to EEO guidelines.

Vacancy expired!


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