QC Analytical Data Reviewer

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🕒 June 17

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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

• Ensures the quality of laboratory data and reports. • Reviews chromatographic data, related notebooks and sample results for scientific soundness, completeness, accurate representation of the data, and final reported results. • Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). • Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner. • Communicates with laboratory staff to proactively address the quality of laboratory documentation. • Prepares QC statements noting deficiencies with the analytical data set or notebooks. • Reports deficiencies to the project leader for correction. • Facilitates in 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

• BSc in Science or related field required • 2+ years of QA/QC analytical experience is essential (gaining thorough knowledge of chromatography and including experience in reviewing analytical data/results) • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP • Strong verbal and written communication skills • Strong technical knowledge including an understanding 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.

🏖️ Benefits

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