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Senior Quality Control Associate (Fremont)
Senior Quality Control Associate (Fremont)Astrix • Fremont, CA, United States
Senior Quality Control Associate (Fremont)

Senior Quality Control Associate (Fremont)

Astrix • Fremont, CA, United States
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Our client is a biotechnology company combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases.

Title : Senior Research Associate - Analytical Sciences

Location : South San Francsico, CA Onsite

Pay : $30-45 / hr Depends on experience level

Contract to potential hire (Benefits included)

We are seeking a highly skilled Senior Research Associate to support our QC laboratory within Analytical Sciences. This hands-on role is responsible for managing day-to-day QC lab operations, executing DS / DP release and stability testing, contributing to method lifecycle activities, and delivering high-quality, compliant analytical data to advance our pipeline programs.

Key Responsibilities

  • Oversee daily QC lab activities to ensure efficient, accurate, and compliant testing.
  • Manage stability studies and ensure all associated testing is completed on schedule.
  • Conduct method validation, qualification, and optimization.
  • Maintain and manage SOPs, deviations, CAPAs, and change control processes.
  • Perform and oversee DS / DP release testing, characterization, and other analytical studies.

Qualifications

  • Bachelors degree in Chemistry, Biology, Biochemistry, or a closely related field.
  • 24 years of practical experience in a GMP-regulated QC or analytical laboratory setting.
  • Proficient in analytical techniques such as HPLC / UPLC, ELISA, PCR / qPCR, CE, or comparable methods.
  • Solid experience in quality processes, including CAPA management, audits, and change control.
  • Strong documentation and record-keeping skills, with thorough knowledge of cGMP standards and data integrity principles.
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    Quality Control Associate • Fremont, CA, United States

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