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Data Reviewer, GMP, Cell Lab
Thermo Fisher Scientific. Review routine and complex analytical analysis experiments involving pharmaceutical and biopharmaceutical compounds .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong technical knowledge of laboratory procedures, methodology, and standards, with a focus on compliance with SOPs, GLP, and GMP regulations. Capable of conducting thorough data reviews and providing clear feedback while advocating for quality improvements in laboratory practices.
Highest-signal resume keywords
GMP ComplianceChromatography ExperienceData Review ExpertiseSOP KnowledgeAnalytical Method Evaluation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Analytical AnalysisLaboratory ProceduresData Quality MonitoringChromatographic TechniquesMethodology ComplianceSOP AdherenceQuality ControlProcess ImprovementTechnical DocumentationData Evaluation
Soft Skills
Attention to DetailVerbal CommunicationWritten CommunicationCollaborationTraining Ability
Tools & Technologies
Laboratory EquipmentStandard Office EquipmentData Management Systems
Industry Keywords
PharmaceuticalBiopharmaceuticalGLPGMPFederal Regulations
About the role
Key responsibilities & impact- Review routine and complex analytical analysis experiments involving pharmaceutical and biopharmaceutical compounds
- Ensure analyses follow validated or experimental procedures and comply with methodology, protocols, product specifications, SOP acceptance criteria, and GMP
- Review data entered into databases and reports and monitor laboratory data quality
- Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs
- Review sample results for scientific soundness, completeness, accurate data representation, and final reported results
- Communicate with laboratory staff to maintain the quality of laboratory documentation
- Deliver clear and concise findings regarding deficiencies in analytical data or reports
- Escalate significant deficiencies to the project leader or supervisor
- Facilitate discussions with laboratory staff on documentation best practices and quality findings
- Advocate for quality and review process changes
- Identify and support process improvement initiatives
- Perform other duties as assigned
Requirements
What you’ll need- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, including a drug screening
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
- 2+ years of comparable experience, or equivalent combination of education, training, and experience
- Previous experience with formal data review in a GMP laboratory strongly preferred
- Previous chromatographic experience preferred
- Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP
- Thorough knowledge of chromatography may be required
- Strong technical knowledge of laboratory procedures, methodology, and standards
- Strong verbal and written communication skills
- Strong attention to detail
- Ability to train staff on basic review techniques
- Ability to independently review laboratory reports and analytical methods
- Ability to manage multiple and changing priorities
- Ability to provide clear and concise feedback and documentation of results
- Ability to work collaboratively and efficiently in a remote capacity
- Ability to communicate, receive, and understand information and ideas with diverse groups
- 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 use and learn standard office equipment and technology proficiently
- Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities
Benefits
Comp & perks- Fully remote work arrangement
- Accessibility services and accommodations for job seekers with disabilities during the application process