Data Reviewer - GMP, Cell Lab

Overview

Review routine and complex analytical laboratory data for pharmaceutical and biopharmaceutical compounds in accordance with validated methods, protocols, specifications, SOPs, and GMP requirements.

What you'll do

• Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs.
• Review sample results for scientific soundness, completeness, accuracy, and final reporting.
• Monitor the quality of laboratory data entered into databases and reports.
• Communicate with laboratory staff to improve documentation quality.
• Document and escalate significant deficiencies in analytical data or reports.
• Support process improvement and laboratory data-review changes.

What you'll need

• At least 2 years of comparable experience, or an equivalent combination of education, training, and experience.
• Bachelor's degree or equivalent relevant academic or vocational qualification.
• Knowledge of laboratory procedures, analytical methodology, and applicable standards.
• Knowledge of SOPs and federal GLP and GMP regulations.
• Ability to independently review laboratory reports and analytical methods.
• Strong verbal and written communication skills.
• Strong attention to detail and ability to manage changing priorities.

Nice to have

• Formal data-review experience in a GMP laboratory.
• Chromatographic experience.
• Thorough knowledge of chromatography.

Details

• Fully remote role supporting a GMP laboratory in Middleton, Wisconsin.
• Applicants must be located within the United States.
• Applicants must be legally authorized to work in the United States without sponsorship.