QC Associate II

Company: LanceSoft Inc
Location: Fremont
Posted on: January 23, 2023

Job Description:

Position: QC Associate II
Duration: 12 months
Location: Fremont, CA, 94555

Shift: 1st
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 timeline right the first time Documents work according to cGMP and cGDP.
  
• Adheres to established regulations and follows cGMP established by site.
  
• Reports abnormalities and deviations in a timely and accurate manner.
  
• Adheres to safety standards and identifies unsafe situations / habits and escalates approriately.
  
• 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 experience; or Associate Degree with 2 years experience
      
      Required:
      " ROOT CAUSE ANALYSIS
      " SAFETY STANDARDS
      " FILING
      " SOP
      " RECONCILIATION
      
      Additional:
      " CGMP
      " GMP
      " OPERATIONS
      " RISK ASSESSMENTS
      " STOCKING
      " DATA MANAGEMENT

Keywords: LanceSoft Inc, Fremont , QC Associate II, Other , Fremont, California