Data Reviewer, Biopharma

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• Ensure the integrity and quality of laboratory and chromatographic data and reports • Ensure analyses follow validated or experimental analytical procedures and compare results against methodology, protocols, product specifications, SOP acceptance criteria, and GMP • Review data entered into databases and reports and monitor laboratory data quality • Review chromatographic data, related notebooks, and sample results for scientific soundness, completeness, accurate data representation, and final reported results • Evaluate data for compliance with analytical methods, client criteria, GLP, and GMP • Deliver clear and concise review findings identifying deficiencies in analytical data or reports • Communicate with laboratory staff to proactively address laboratory documentation quality • Prepare QC statements identifying deficiencies in analytical datasets or notebooks • Report deficiencies to the project leader for correction • Facilitate discussions with laboratory staff regarding documentation best practices and quality findings • Advocate for quality and review process changes • Identify and support process improvement initiatives

🎯 Requirements

• BSc in Science or related field required • 2+ years of QA/QC analytical experience essential • Thorough knowledge of chromatography, including reviewing analytical data and results • Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP • Strong verbal and written communication skills • Strong technical knowledge of laboratory procedures, methodology, and standards • Ability to independently review laboratory reports and analytical methods • Strong attention to detail • Ability to provide clear and concise feedback and/or documentation of results • Ability to communicate, receive, and understand information and ideas with diverse groups of people • Ability to work upright and stationary and/or standing during typical working hours • Ability to lift and move objects up to 25 pounds • Ability to work in non-traditional work environments • 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

• Immigration and visa support for successful applicants and dependents • Tax consultations • Other basic destination services • Reasonable accommodation for individuals with disabilities • Equal opportunity employment