QC Data Reviewer - Boston MA - tbd
Cambridge, MA 02210 US
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Title: QC Data Reviewer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Temp to Perm
- Pay rate: $29/hr
- Job Location: Hybrid in March (Cambridge, MA)
- Job#: bh 14140
QC Data Reviewer
The QC Data Reviewer (Contractor) will be part of the Bioanalytical Preclinical Development team for Cell and Gene Therapy organization. The principal responsibility of this role is to review Pharmacology and Bioanalytical data, protocol compliance and documentation in support of In vivo and In vitro studies.
Responsibilities and Duties
- Responsible to review Pharmacology and Bioanalytical data and electronic lab notebook documentation to ensure accuracy and quality 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 with Bioanalytical Operations
- Collect metrics data on Pharmacology and 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
- To process quotes, SOWs, contracts, MSA as part of collaboration with external vendors
- Education: Minimum of Bachelor’s degree (B.A./B.S.) or equivalent in a biological science.
- Experience: 2+ years of experience in biopharmaceutical research setting with a focus on Bioanalysis; experience with GxP-based laboratory setting and regulatory guidance is preferred.
- Working knowledge of various laboratory technologies such as Capillary Western Blot, qPCR, ELISA, plate reader etc
- Excellent inter-personal, communication and organizational skills
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