TU PRÓXIMO CAPÍTULO
Data Reviewer – Cell Lab
Sobre el puesto
• Support Cell Laboratory teams in ensuring the integrity and quality of laboratory and chromatographic data and reports
• Ensure analyses follow validated or experimental analytical procedures and compare results against methodology, protocol and product specifications, SOP acceptance criteria, and GMP
• Review data entered into databases and reports and monitor laboratory data quality
• Ensure the quality of laboratory data and reports
• Review chromatographic data, related notebooks, and sample results for scientific soundness, completeness, accurate data representation, and final reported results
• Evaluate data for compliance with analytical methods, client criteria, GLP, and GMP
• Deliver clear and concise review findings, noting deficiencies in analytical data or reports
• Communicate with laboratory staff to proactively address laboratory documentation quality
• Prepare QC statements noting deficiencies in analytical data sets or notebooks
• Report deficiencies to the project leader for correction
• Facilitate conversations with laboratory staff about best documentation practices and quality findings
• Advocate for quality and review process changes
• Identify and support process improvement initiatives
• BSc in Science or related field required
• 2+ years of QA/QC analytical experience, including thorough knowledge of cell-based assays and experience reviewing analytical data/results
• Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP
• Strong verbal and written communication skills
• Strong technical knowledge of laboratory procedures, methodology, and standards
• Ability to independently review laboratory reports and analytical methods
• Strong attention to detail
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to communicate, receive, and understand information and ideas with diverse groups of people
• Ability to work upright and stationary and/or standing for typical working hours
• Ability to lift and move objects up to 25 pounds
• Ability to work in non-traditional work environments
• Ability to use and learn standard office equipment and technology proficiently
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments
• Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities
• Fully remote work arrangement
• Standard Monday–Friday work schedule