Quality Control Analyst I

Redwood City, CA 94063

Posted: 10/22/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 18074

Job Description


 

What You’ ll Do
  • The Quality Control Analyst is responsible for release testing in support of nonclinical and clinical viral vector products in compliance with GxP requirements.
  • Understands and follows standard operating procedures (SOPs).
  • Performs  release, stability, and in-process testing of materials, samples, and final products; works with mammalian samples and cell cultures.
  • Performs analysis and interpretation of test results, identifies  deviations,  and makes appropriate recommendations.
  • Participates in method and equipment qualification/validation studies; generates protocols, executes and coordinates experiments, and drafts reports.
  • May assist in assay development and nonclinical sample testing to support IND-path studies.
  • Other responsibilities may be assigned as needed

 

About You
  • Relevant scientific degree with minimum 1-3 years of experience in a bio-pharma analytical laboratory.
  • Experience in quality control desired.  A strong background in molecular biology is desired. Experience with  viral  vector (adeno-associated virus) product is a plus.
  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries desired. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative and/or digital PCR, ELISA, and cell-based methods.
  • Knowledge of statistical methods applicable to the analysis of experimental data.
  • Proficient in general and non-routine laboratory skills.
  • Excellent interpersonal, communication and organizational skills.
  • Flexibility in  problem solving to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as  Soft Max  Pro desired.

 

Meet Your Recruiter

Ashley Lee

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