Operational Data Steward – Lexington, MA
Must be able to work on a W2
Bioanalytical Data reviewer/ Quality Control - Contractor
This position is responsible for the quality control of all nonGLP data generated in the Nonclinical Pharmacology group.
Key Responsibilities:
• Work closely with scientists within the ADME group to verify bioanalytical data generated using HPLC-FD and LC-MS/MS.
• Work closely with scientists within the in-vivo pharmacology group to verify in-vivo and Pharmacodynamic (qPCR) data.
• Review and verify all data to ensure accuracy, completeness, and compliance with internal guidelines and acceptance criteria.
• Generate reports/checklist for all QC findings, along with subsequent discussions with relevant scientists in order to resolve issues.
• Interpret data and provide insight for in-vivo studies, ensuring alignment with study objectives and protocols.
• Collaborate with cross-functional teams to support raw data verification.
• Ensure data integrity and quality by adhering to internal and other regulatory guidelines. .
• Enhance QC initiatives through the identification and implementation of best practices in data review and analysis.
Qualifications:
• Strong analytical skills with a keen eye for detail.
• Familiarity with analytical software’s.
• Familiarity with regulatory guidelines and standards related to bioanalytical data review.
• Excellent communication and collaboration skills.
Experience:
• Prior experience in quality control of Scientific data.
• Minimum of 1 year experience with data review/QC, preferred 3-5 years of experience.
Education:
• A degree in a relevant scientific discipline, such as Biochemistry, Biotechnology, Pharmacology, or related fields
Term & Start
- FT, M-F 40hr/week
- Pay Rate: Up to $64K Annually
- Onsite in Lexington, MA – Hybrid 3 days a week
