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Full-Time

Data Reviewer

QC Specialist

Posted on 7/2/2024

BioAgilytix

BioAgilytix

501-1,000 employees

Specializes in bioanalytical services for pharmaceuticals

Data & Analytics
Food & Agriculture
Biotechnology

Junior, Mid

Boston, MA, USA

Category
Lab & Research
Life Sciences
Medical Research
Requirements
  • Bachelor’s degree in biological science or related field
  • 2-10 years’ experience working in biotech, pharmaceutical, CRO/CMO or similar organization
  • Knowledge and/or extensive knowledge of GxP regulations
  • Two-Four (2-4) years’ experience performing data review in a GxP environment
  • Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR
Responsibilities
  • Perform Quality Control (QC) technical, scientific, and compliance review of data and documentation
  • Identify deviations, OOS and OOT associated with Bioanalytical Operations data
  • Issue QC review observations and work closely with the scientific staff
  • Collect metrics data used to monitor the QC reviews and may identify process improvements
  • Assist in educating, guiding, and influencing the scientific staff in regard to best practices in GxP compliance

With a focus on bioanalytical services catering to the pharmaceutical and biotechnology sectors, this company offers a collaborative and scientifically rigorous environment. Their use of cutting-edge technologies like qPCR, flow cytometry, and immunoassays for assay development, validation, and sample analysis ensures employees are at the forefront of scientific innovation. Moreover, their global presence with laboratories in the US, Australia, and Germany enriches the professional experience through diverse interdisciplinary interaction and adherence to top-tier regulatory standards, making it a distinguished place to pursue a career in drug development and bioanalytics.

Company Stage

Series A

Total Funding

$30.2M

Headquarters

Durham, North Carolina

Founded

2008

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

0%

2 year growth

6%