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Category: Life Sciences
Job Number: 20435
Position: Bioanalytical Quality Control Data Reviewer
Location: Boston, MA - Hybrid - 2 days/week onsite
Job Type: Contract
Duration: 6+ months
This company is working to discover and develop innovative genetic therapies with the potential to provide transformative benefit to patients. This company is currently advancing multiple CRISPR-based genetic therapies that have the potential to cure or stop the progression of disease, including for degenerative neurological and muscular diseases. This company is seeking a creative, self-motivated individual with a passion for science to join our team. This is a fantastic opportunity to work on cutting edge science, apply state-of-the-art gene editing technologies, and take part in discovering and developing next-generation of gene and cell therapies. The QC data reviewer will be part of the Bioanalytical Preclinical Development team within Cell and Gene Therapy organization. The principal responsibility of this role is to review Bioanalytical data, protocols compliance and documentation in support of in vivo and in vitro studies.
- Responsible to review Bioanalytical data and electronic lab notebook documentation to ensure accuracy and integrity of data
- Perform detailed document quality review of protocols, method development reports and study reports to verify integrity of data in support of regulatory submission
- Ensure Good Research Practices are observed within Bioanalytical Operations
- Collect metrics data on Bioanalytical assay quality controls to identify data trends and atypical results for in-process improvement initiatives
- Collaborate closely with cross-functional groups to ensure timely deliverables of data and reports.
- Participate in updating Bioanalytical protocols and reports for review and approval.
- Communicate with Bioanalytical scientists and supervisors on technical issues, investigations, and data discrepancies
- Minimum of Bachelor's (B.S) degree in biological science with 4+ years or Master's degree with 2+ years of working experience in biopharmaceutical research setting with a focus on Bioanalysis; experience with GxP-based laboratory setting and regulatory guidance is preferred.
- Demonstrated experience in assay development and data analysis.
- Working knowledge of various laboratory technologies such as Capillary Western Blot, qPCR, ELISA, plate reader, Luminex etc
- Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
Queen Consulting Group is an equal opportunity employer. Our goal is to promote an environment that helps our employees and clients appreciate the benefits that diversity provides.
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