Quality Assurance Label Specialist

hace 5 días


San Juan, San Juan, Puerto Rico Integrated Resources A tiempo completo

Job Title: Quality Assurance Label Specialist

Job Summary:

The Quality Assurance Label Specialist will support site Label Control activities at S-12 in accordance with Client policies, standards, procedures, and Global cGMPs. This role is responsible for performing in-process and drug product label printing activities, ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).

Key Responsibilities:

  • Perform in-process and drug product label printing activities
  • Ensure accurate and timely issuance of labels for manufacturing and packaging labeling activities
  • Support site Label Control activities at S-12
  • Coordinate with production teams to ensure timely issuance of labels
  • Perform training of label control and issuance requirements for internal personnel as needed
  • Ensure standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks
  • Write, review, and update SOPs as required
  • Provide support during internal and health authority inspections and audits of facility
  • Maintain knowledge of current GMPs and regulatory guidelines

Requirements:

  • B.S. Degree required, minimum 2 years relevant work experience
  • Equivalent combination of education and experience acceptable

Working Conditions:

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.



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