Data Reviewer – GMP Labs
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Wisconsin • United States
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About the role
- 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 the 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, and final reported results
- 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
- Escalates significant deficiencies to the project leader or supervisor for assessment
- Facilitates conversations with lab staff on best documentation practices and addressing quality findings
- Advocates for quality and review process changes
- Identifies and supports process improvement initiatives
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’) or equivalent combination of education, training, and experience
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Previous experience with formal data review in GMP Lab strongly preferred
- Thorough knowledge of compendial and physicals strongly preferred
- Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards
- Strong verbal and written communication skills
- Strong attention to detail
- Ability to balance time and remain focused on work to meet goals
- Ability to train staff on basic review techniques
- Ability to independently review laboratory reports and analytical methods
- Ability to deal with multiple and changing priorities
- Ability to provide clear and concise feedback and/or documentation of results
- Ability to work in a collaborative team environment
- Ability to work efficiently in a remote capacity
Benefits
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical analysisdata reviewlaboratory proceduresmethodologySOPsGLPGMPcompendial knowledgephysical analysisprocess improvement
Soft Skills
verbal communicationwritten communicationattention to detailtime managementtrainingindependent reviewfeedback documentationcollaborationadaptabilityproblem-solving
Certifications
Bachelor's degreeformal academic qualificationvocational qualification