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Specialist I
4 weeks ago
Please ONLY local candidates to Summit NJ
**Our client, a leading pharmaceutical company is hiring a Label Specialist for a 6+ months contracting assignment. Deviations, CAPA, SOP writing, Project Management, Pharma background
Degree required, minimum 2 years relevant work experience
ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO)
Responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives
Must have knowledge and experience with GMP, Quality, and compliance
Good understanding of electronic document management and manufacturing execution systems
Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies
Responsible for issuing clinical and commercial in-process and final product labels for labeling operations
Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management
Maintains knowledge of current GMPs and regulatory guidelines
