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
- 12-month contract
- FT, M-F 40hr / week
- Pay Rate : $32 / HR ($64K Annually)
- Onsite in Lexington, MA Hybrid 3 days a week
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