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PDS Tech Inc Quality Control Analyst (Mid) in Berkeley, California

PDS Tech Inc. is searching for a Quality Control Analyst, in Berkeley, CA.

Description:

The QC Raw Material Chemistry group is responsible for laboratory assay testing of raw materials, water, in-process drug substance, and drug product to ensure quality.

Position Summary:

The candidate analyst will create Laboratory Information Management System (LIMS) master data to be used for recording raw material testing data and documentation.

Position Duties & Responsibilities:

  • Responsible for setting up LIMS for raw material testing which include creating, testing, implementing LIMS master data.

  • Assess raw material test methods to compile assay parameters to be captured in LIMS system.

  • Create master data in LIMS for entry of assay testing parameters.

  • Perform quality testing of LIMS master data setup.

  • Work with an interdisciplinary team consisting of laboratory analysts, raw material subject matter experts, IT and LIMS experts in the creation and implementation of LIMS master data.

  • Document, compile, sort, and archive cGMP data records.

Requirements/Preferences:

Education Requirement(s):

Minimum Education:

  • Bachelor's Degree in chemistry, computer or related field.

Minimum Experience:

  • Minimum 1+ years of experience in wet chemistry and raw material analysis and LIMS.

Skill & Competency Requirements:

  • Knowledge of computer software system setup (i.e LIMS and Windows scripting).

  • Basic knowledge of instrumental analysis and raw material testing.

  • Familiar with cGMP.

Preferences:

  • Prior experience working in a chemistry laboratory environment is preferred.

  • Experience in programming, windows scripting and LIMS is preferred.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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