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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

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