QC Data Reviewer
3 weeks ago
Job Title: Data Quality Control Specialist/ Operational Data Steward
Job Location: Lexington, MA- Hybrid Role (3days/week onsite)
Job Duration: 12 Months+
MUST HAVES:
1. Experience being responsible for quality control of all scientific data generated within the Nonclinical Pharmacology group
2. Familiarity with Bioanalytical sample and data analysis
3. Attention to detail and experience with raw data QC
Bioanalytical Data reviewer/ Quality Control - Contractor
This position is responsible for the quality control of all nonGLP data generated in the Nonclinical Pharmacology group within GNAT unit of Client.
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
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