Quality - QA CTO Label Specialist QA CTO Label Specialist

Company: Eclaro
Location: Summit
Posted on: March 20, 2023

Job Description:

QA CTO Label Specialist

Job Number: 23-00545
-

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA CTO Label Specialist for our client in Summit, NJ. -

-

Eclaro's client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you're up to the challenge, then take a chance at this rewarding opportunity!

-

Position Overview:

• 
  
• The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records.
  
• To succeed in this role, you will have a strong attention to detail and an analytical mindset.
  
  -
  
  Qualifications:
  
  
  • 
    
  • Education: Bachelors degree or equivalent
    
  • Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment
    
  • Some document management experience
    
  • Crystal reports experience preferred
    
  • Strong communication and customer service skills.
    
  • 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)
    
  • Develop and improve label issuance processes to drive operational efficiency
    
  • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
    
  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively
    
  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
    
  • 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.)
    
  • Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network
    
    -
    
    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.
      
    • Performs 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.
      
      -
      
      If hired, you will enjoy the following Eclaro Benefits:
      
      
      • 
        
      • 401k Retirement Savings Plan administered by Merrill Lynch
        
      • Commuter Check Pretax Commuter Benefits
        
      • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
        
        -
        
        If interested, you may contact:
        
        Paul Quibuyen
        
        
        
        6466952942
        
        
        
        -
        
        Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Keywords: Eclaro, New York , Quality - QA CTO Label Specialist QA CTO Label Specialist, IT / Software / Systems , Summit, New York