Bioanalytical Data Reviewer

2 months ago


Lexington, United States GForce Life Sciences Full time

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


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