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Quality Assurance Specialist

1 month ago

Summit, United States SSi People Full time

Job Title: QA CTO Label Specialist

Contract Duration: 6 months (Possibility of extension or conversion for the right candidate depending on performance)


Skills Required:

  • Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment preferred.
  • Some document management experience.
  • Crystal reports and BarTender experience preferred.
  • Strong communication and customer service skills.
  • 1+ years of experience in the Biopharma
  • 1+ years of quality experience
  • 1+ years of labeling Experience
  • 3+ years with MS Office 365


Key Responsibilities:

  • Perform in-process and drug product label printing activities, ensuring accurate and timely issuance of labels for manufacturing and packaging.
  • Support the establishment, maintenance, and continuous improvement of the clinical and commercial label control process.
  • Issue clinical and commercial in-process and final product labels for labelling operations, ensuring compliance with health authority requirements.
  • Coordinate with production teams for timely issuance of labels.
  • Train internal personnel on label control and issuance requirements as needed.
  • Support internal and health authority inspections of the facility.