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Data Reviewer, Biosafety – GMP
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 expertise in analytical data review and compliance with GLP and GMP standards, with a strong focus on quality assurance and process improvement in laboratory settings. Proficient in chromatography and laboratory methodologies, with effective communication and training abilities.
Highest-signal resume keywords
GMP Laboratory ExperienceAnalytical Data ReviewChromatography KnowledgeSOP ComplianceStrong Attention To Detail
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 EvaluationQuality AssuranceProcess ImprovementTechnical Report ReviewData Quality MonitoringDocumentation PracticesTraining StaffCompliance Standards
Soft Skills
Verbal CommunicationWritten CommunicationAttention To DetailProblem-SolvingAbility To Work Under Pressure
Tools & Technologies
Standard Office EquipmentLaboratory Databases
Industry Keywords
GLPGMPSOPsFederal RegulationsPharmaceutical CompoundsBiopharmaceutical Compounds
About the role
Key responsibilities & impact- Review routine and complex analytical analysis experiments involving pharmaceutical and biopharmaceutical compounds
- Evaluate laboratory data for compliance with analytical methods, client directives, SOPs, GLP, GMP, and acceptance criteria
- Review sample results for scientific soundness, completeness, accurate data representation, and final reported results
- Review data entered into databases and reports and monitor laboratory data quality
- Communicate with laboratory staff to maintain the quality of laboratory documentation
- Deliver clear and concise review findings identifying deficiencies in analytical data or reports
- Escalate significant deficiencies to the project leader or supervisor
- Facilitate discussions with laboratory staff on documentation 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- 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 Lab strongly 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 work efficiently in a remote capacity
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, including drug screening
- Ability to lift and move objects up to 25 pounds
- Ability to use and learn standard office equipment and technology proficiently
- Ability to work upright and stationary and/or standing for typical working hours
- Ability to work in non-traditional work environments
- Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities
Benefits
Comp & perks- Fully remote work arrangement
- Full-time employment
- Career development resources and support
- Accessibility assistance or accommodations during the application process
- Equal employment opportunity and affirmative action protections