Data Reviewer - Cell Lab, GMP (Sunday - Thursday)

Thermo Fisher Scientific • Middleton, WI

2d • Remote

About The Position

The Data Reviewer supports Thermo Fisher Scientific’s GMP laboratory in Middleton, Wisconsin, in a fully remote role open to applicants anywhere in the United States. The position reviews routine and complex analytical experiments involving pharmaceutical and biopharmaceutical compounds, formulations, and biological matrices. It ensures analyses follow validated or experimental procedures and that results comply with methodologies, protocols, product specifications, SOP acceptance criteria, and GMP requirements. The reviewer also checks database entries and reports and monitors laboratory data quality, applying a thorough understanding of laboratory procedures to independently review complex analyses.

The role is scheduled for first shift, Sunday through Thursday. Candidates must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
• At least 2 years of comparable experience, or an equivalent combination of education, training, and experience.
• Thorough knowledge of SOPs and federal regulations, including GLP and GMP.
• Strong technical knowledge and understanding of laboratory procedures, methodology, and standards.
• Strong verbal and written communication skills.
• Strong attention to detail.
• Ability to balance time and remain focused to meet goals.
• 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 documentation of results.
• Ability to work collaboratively and efficiently in a remote capacity.
• Ability to demonstrate behaviors aligned with Thermo Fisher Scientific’s 4i Values.
• Must be legally authorized to work in the United States without sponsorship.
• Must pass a comprehensive background check, including drug screening.

Nice To Haves

• Previous experience with formal data review in a GMP laboratory is strongly preferred.
• Thorough knowledge of chromatography may be required.

Responsibilities

• Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs.
• Review sample results for scientific soundness, completeness, accurate representation of the data, and accuracy of final reported results.
• Communicate with laboratory staff to proactively maintain the quality of laboratory documentation.
• Clearly and concisely document review findings and deficiencies in analytical data or reports.
• Escalate significant deficiencies to the project leader or supervisor for assessment.
• Facilitate conversations with laboratory staff about documentation best practices and addressing quality findings.
• Advocate for quality and review process changes.
• Identify and support process improvement initiatives.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level