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QC Associate II

Lancesoft

 

Fremont, CA, USA

Posted On: 4 days ago
Experience: 2+ years
Availability: Hybrid
Openings: 1
Category: QC Associate
Tenure: No Preference/Any
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Description

You will perform analytical testing and maintain compliance within a regulated laboratory environment.

This role is on-site.

Responsibilities

  • Perform Total Organic Carbon (TOC) and conductivity testing using Sievers M9 TOC Analyzers and Mettler Toledo SevenExcellence meters.
  • Execute raw material testing including wet chemistry, HPLC, FT-IR, osmolarity, and titrations per USP, EP, and JP requirements.
  • Document all laboratory work following cGMP and cGDP standards.
  • Investigate data discrepancies to identify root causes and implement process improvements.
  • Train technicians and associates on laboratory operations, methods, and compliance topics.

Required Skills

  • 2+ years of experience in a cGMP regulated industry.
  • Proficiency in HPLC and wet chemistry techniques.
  • Experience with TOC and conductivity testing.
  • Knowledge of Quality Control protocols and LIMS.
  • Ability to work within FDA, EMEA, MHRA, and PMDA regulated environments.
  • Familiarity with compendia requirements (USP, EP, JP).
  • Understanding of 5S laboratory maintenance standards.

Education

Any Graduate

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