Data Reviewer – Small Molecule, GMP

Role Overview

• Performs review of a variety of routine and complex analytical analysis experiments
• Ensures analyses are following validated or experimental analytical procedures
• Reviews data entered into databases and reports and monitors the quality of laboratory data
• Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs
• Reviews sample results for scientific soundness, completeness, accurate representation of the data
• Communicates with laboratory staff to proactively maintain the quality of laboratory documentation
• Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner
• Escalate significant deficiencies to the project leader or supervisor for assessment
• Facilitates in conversations with lab staff on best documentation practices and addressing quality findings

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
• Demonstrated knowledge of PCR and sequencing strongly preferred
• Previous experience with formal data review in GMP Lab strongly preferred
• Previous experience with method validation or method validation data review strongly preferred
• Previous experience with chromatographic review and Empower strongly preferred
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
• Thorough knowledge of chromatography may be required.
• Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards
• Ability to train staff on basic review techniques
• Ability to work in a collaborative team environment
• Ability to work efficiently in a remote capacity

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off