Quality Assurance Label Specialist
hace 5 días
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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