Job Description

83837

**Please ONLY local candidates to Summit NJ

**This position is scheduled for Wed-Sat (6:30 am -4:30 pm)

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Label Specialist for a 6+ months contracting assignment. This is a 100% onsite position. This position is scheduled for Wed-Sat (6:30 am -4:30 pm).

Must have skills:

• Deviations, CAPA, SOP writing, Project Management, Pharma background
• B.S. Degree required, minimum 2 years relevant work experience

Pay: $33-34/hour W2

Location: Summit NJ

Responsibilities:

• Functional responsibilities include 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)
• 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
• Responsible for ensuring accurate printed information on labels in compliance with health authority requirements
• 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

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