QC Data Reviewer

3 weeks ago

new york city norwood, United States Randstad Life Sciences US Full time

Quality Control, Bioassay Data Reviewer

6 Months

Norwood, MA

Hourly pay- $56


  • Must have 5 years QC GMP experience in Data Review


Shift: 11am - 7pm, M-F


Job Summary

In this role, you will support QC Bioassay Labs with review of test records and documents.


Job Responsibilities

  • Review executed QC test records for molecular and cell based assays
  • Review Audit trails
  • Review reagent and equipment logbooks
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  • Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  • Additional duties may be assigned.


Education & Qualifications

  • STEM degree with 5 years of experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell-based assays (e.g. qPCR, sequencing, potency, mammalian, and bacterial cell culture)
  • Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review
  • Previous experience using Labvantage LIMS and LES worksheets
  • Excellent communication skills (verbal and written)
  • Working knowledge of USP, ISO, FDA and ICH guidelines
  • Experience with laboratory information systems
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Working knowledge of Data Integrity principles and Good Documentation Practices

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