QA Label Specialist

Joulé; Summit (NJ); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

401(k) plan

Job summary

A leading company in staffing seeks a QA Label Specialist in Summit, NJ. The role involves overseeing labeling processes in a cGMP environment, ensuring compliance, and supporting product launches. Ideal candidates should have a strong QA background and Bachelor's degree, with 2+ years of relevant experience.

Qualifications

• 2+ years of experience in a cGMP/FDA regulated environment.
• Experience in labeling in regulated environments.
• Familiarity with quality processes and regulatory guidelines.

Responsibilities

• Issuing clinical and commercial product labels.
• Ensuring compliance with health authority requirements.
• Coordinating with production teams for timely label issuance.

Skills

Attention to detail

Quality assurance

Document management

Project management

Regulatory compliance

Education

Bachelor's degree

Tools

MS Office

Crystal Reports

Job description

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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.
    
    
    
    Ref: #568-Clinical

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Staffing and Recruiting

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