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Quality Assurance Label Control Specialist

4 weeks ago

Summit, New Jersey, United States Net2Source Inc. Full time
Job Title: Quality Assurance Label Control Specialist

Net2Source Inc. is seeking a highly skilled Quality Assurance Label Control Specialist to support the cGMP Label Control operations for the client site.

Key Responsibilities:

  • Coordinate, issue, reconcile, and manage production labels and records.
  • Ensure accurate printed information on labels in compliance with health authority requirements.
  • Train internal personnel on label control and issuance requirements.
  • Write, review, and update standard operating procedures (SOPs) related to job responsibilities.
  • Support new drug product launches, new market, and other quality management activities.
  • Provide support during internal and health authority inspections and audits of facility.

Requirements:

  • Bachelor's degree with 2+ years of experience in a cGMP/FDA regulated environment.
  • Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
  • Strong communication and customer service skills.
  • Strong computer skills with MS Office and Quality Systems.
  • Ability to work effectively and collaboratively at a fast pace with cross-functional departments.

Working Conditions:

Weekend and off-shift support may be required. Occasional lifting of heavy weights up to 25 to 35 lbs.