Data Reviewer – Small Molecule

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🔥 0 minutes ago

🧀 Wisconsin – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Performs review of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices. • Ensures analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). • 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. • Escalate significant deficiencies to the project leader or supervisor for assessment. • Facilitates conversations with lab staff on best documentation practices and addressing quality findings. • Identifies and supports process improvement initiatives. • Performs other duties as assigned.

🎯 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 • Thorough knowledge of chromatography may be required • Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards • Ability to train staff on basic review techniques. • Ability to work efficiently in a remote capacity

🏖️ Benefits

• We support and encourage individuals to create a healthy and balanced environment where they can thrive.

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