Bioassay Data Quality Assurance Professional

4 days ago


Norwood, New Jersey, United States Randstad Life Sciences US Full time
About the Opportunity

We are looking for a highly skilled Bioassay Data Quality Assurance Professional to join our team in Norwood, MA.

The ideal candidate will have at least 5 years of experience in a cGMP laboratory setting and a strong understanding of molecular biology and cell-based assays.

Responsibilities

The responsibilities of this role include:

  • Reviewing executed QC test records for molecular and cell-based assays.
  • Reviewing audit trails and reagent and equipment logbooks.
  • Verifying data accuracy and completeness in accordance with GxP regulations and company policies.
  • Collaborating with cross-functional teams to resolve data discrepancies and implement corrective actions.
Requirements

To be considered for this role, you must have:

  • A STEM degree and at least 5 years of experience in a cGMP laboratory setting.
  • Hands-on experience in molecular biology and cell-based assays.
  • Previous experience reviewing data in a GMP environment for GDP/GMP compliance.
  • Working knowledge of USP, ISO, FDA, and ICH guidelines.
  • Experience with laboratory information systems.

The estimated salary for this role is $56.77/hour, and it involves working 11am - 7pm, Monday through Friday in Norwood, MA.



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