Data Review Scientist

The Data Review Scientist is responsible for reviewing laboratory data and supporting documentation to ensure compliance with standard operating procedures (SOPs), compendial standards, and current Good Manufacturing Practices (cGMP). This role requires strong knowledge of analytical instrumentation and scientific principles to evaluate data integrity, verify conclusions, and support accurate reporting., * Review raw laboratory data (e.g., analytical records, notebooks, spectra, chromatograms, and instrument outputs) for accuracy, completeness, and compliance.

• Assess scientific conclusions to ensure they are valid and supported by the data.
• Identify discrepancies, inaccuracies, or incomplete analyses, and collaborate with laboratory staff to resolve issues.
• Ensure laboratory documentation aligns with cGMP, regulatory requirements, and internal procedures.
• Support and maintain compliance within QC/PSG laboratories, including controlled substance systems.
• Communicate effectively across departments to facilitate timely review and approval of data packages.
• Adapt work schedules as needed to meet data review and operational demands.
• Follow all applicable regulatory requirements (DEA, EPA, FDA) and safety procedures.
• Perform additional duties as assigned to support departmental objectives.

• Bachelor's degree in Chemistry or a related field.
• Minimum of 3 years of experience in a pharmaceutical or cGMP-regulated environment preferred.
• Hands-on experience in a laboratory setting preferred.
• Strong knowledge of analytical instrumentation, including GC, HPLC, FTIR, and UV-Vis.
• Solid understanding of data integrity principles and scientific data analysis.
• Ability to manage multiple priorities and work collaboratively in a regulated environment.