Data Reviewer – GMP, Cell & Gene Therapy

🔥 17 hours ago

🧀 Wisconsin – Remote

🧀 Wisconsin – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

😶‍🌫️ Therapist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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

• Review routine and complex analytical analysis experiments involving pharmaceutical and biopharmaceutical compounds • Ensure analyses follow validated or experimental analytical procedures • Compare results with methodology, protocols, product specifications, SOP acceptance criteria, and GMP requirements • Review data entered into databases and reports • Monitor laboratory data quality • Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs • Review sample results for scientific soundness, completeness, accurate data representation, and final reported results • Communicate with laboratory staff to maintain laboratory documentation quality • Deliver clear and concise review findings and identify deficiencies in analytical data or reports • Escalate significant deficiencies to the project leader or supervisor • Facilitate discussions with laboratory staff about documentation practices and quality findings • Advocate for quality and review process changes • Identify and support process improvement initiatives • Perform other duties as assigned

🎯 Requirements

• Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including a drug screening • Bachelor’s degree or equivalent and relevant formal academic / vocational qualification • 2+ years of comparable experience, or equivalent combination of education, training, and experience • Previous experience with formal data review in a GMP Lab strongly preferred • Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP • Thorough knowledge of chromatography may be required • Strong technical knowledge of laboratory procedures, methodology, and standards • Strong verbal and written communication skills • Strong attention to detail • Ability to train staff on basic review techniques • Ability to independently review laboratory reports and analytical methods • Ability to manage multiple and changing priorities • Ability to provide clear and concise feedback and/or documentation of results • Ability to work efficiently in a remote capacity • Ability to communicate, receive, and understand information and ideas with diverse groups of people • Ability to work upright and stationary and/or standing for 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

• Meaningful work supporting health, cleaner, and safer outcomes • Resources to achieve individual career goals • Work with a global team of 100,000+ colleagues • Accessibility assistance/accommodations during the application process • Equal opportunity and affirmative action employment environment