Data Reviewer – Small Molecule, Basic Training in Buckets 1 & 3 Required

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🔥 10 minutes ago

🧀 Wisconsin – Remote

🧀 Wisconsin – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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

• Perform review of a variety of routine and complex analytical analysis experiments conducted on pharmaceutical and biopharmaceutical compounds. • Ensure analyses are following validated or experimental analytical procedures. • Compare results to methodology, protocol and product specifications, SOPs acceptance criteria, and GMP. • Review data entered into databases and reports. • Monitor the quality of the laboratory data. • Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs. • Review sample results for scientific soundness, completeness, and accurate representation of the data. • Communicate with laboratory staff to proactively maintain the quality of laboratory documentation. • Deliver 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. • Facilitate conversations with lab staff on best documentation practices and addressing quality findings. • Advocate for quality and review process changes. • Identify and support 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. • Previous experience with formal data review in GMP Lab strongly preferred. • Basic training in buckets 1 & 3 required. • 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. • 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

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. • Able to work upright and stationary and/or standing for typical working hours. • Able to lift and move objects up to 25 pounds. • Able to work in non-traditional work environments. • Able to use and learn standard office equipment and technology with proficiency. • May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.