QC Associate II

Company: eTeam Inc.
Location: Fremont
Posted on: January 19, 2023

Job Description:

Job Title: QC Associate II
Location: Fremont, CA
Duration: 12 months
Duties:

• 
  
• Executes and coordinates data management in a multi-product facility.
  
• Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, test record issuance and reconciliation, filing, document archival, and document compiling for lot release.
  
• Delivery of high-quality analytical results within the timeline right the first time Documents work according to cGMP and GDP.
  
• Adheres to established regulations and follows cGMP established by the site.
  
• Reports abnormalities and deviations in a timely and accurate manner.
  
• Adheres to safety standards and identifies unsafe situations/habits and escalates appropriately.
  
• Maintains work production areas according to predefined standards (5s).
  
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
  
• Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs, and risk assessments
  
  Skills:
  
  
  • 
    
  • 3-5 years of industry experience depending on educational level (see Education requirements) GMP experience is highly preferred
    
  • Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
    
  • Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals.
    
  • Demonstrates strong attention to detail, and an ability to focus on details of execution
    
    Education
    
    
    • 
      
    • Bachelors Degree in a science or engineering-related field.
      
    • In lieu of a Bachelor's Degree, experience in a regulated or equivalent industry accepted in addition to those specified in the required capabilities:
      
    • High School Degree with 4 years of experience; or
      
    • Associate Degree with 2 years experience
      
      

Keywords: eTeam Inc., Fremont , QC Associate II, Other , Fremont, California