QA Label Specialist

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Job Title:

QA Label Specialist

Location:
Summit, NJ

Hours/Schedule:
Wednesday - Saturday; 2nd Shift (4p - 2am)

Type:Contract


Overview

The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records.


Responsibilities

• Supports all activities for the Quality Assurance Label Control group.
• 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.
• Coordinates with production teams to ensure timely issuance of labels.
• P erforms training of label control and issuance requirements for internal personnel as needed.
• Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
• Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
• Provides support during internal and health authority inspections and audits of facility.
• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
• Performs supplemental investigations/projects as required by Management.
• Maintains knowledge of current GMPs and regulatory guidelines.
  
  
  Requirements
  
  • Bachelors 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.
  • Some document management experience.
  • Crystal reports experience preferred .
  • Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
  • Possess project management skills.
  • Experience interacting with FDA or other regulatory agencies strongly preferred.
  • Strong knowledge of cGMPs and domestic regulatory requirements.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
    
    
    Benefits
    
    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
    
    
    : #568-Clinical

• Seniority level
  
  Entry level

• Employment type
  
  Contract

• Job function
  
  Quality Assurance
• Industries Staffing and Recruiting

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