Data Reviewer, Biosafety (GMP)

Thermo Fisher Scientific • Middleton, WI

3d • Remote

About The Position

The Data Reviewer works in the Biosafety department and supports a GMP laboratory in Middleton, Wisconsin in a fully remote role open to applicants located anywhere in the United States. The role reviews routine and complex analytical experiments involving pharmaceutical and biopharmaceutical compounds in various formulations and biological matrices. It ensures analyses follow validated or experimental procedures and meet applicable methodology, protocol, product specification, SOP acceptance criteria, and GMP requirements. The reviewer checks data entered into databases and reports, monitors laboratory data quality, and independently reviews complex analyses using a thorough understanding of laboratory procedures.

The position requires a bachelor's degree or equivalent relevant academic or vocational qualification, and experience comparable to at least two years, or an equivalent combination of education, training, and experience. Formal data review experience in a GMP laboratory is strongly preferred. Candidates must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening.

The role is performed remotely, while potentially involving exposure to hazards such as infectious agents typically found in healthcare or laboratory environments. Employees must be able to work stationary or standing during typical working hours, move objects up to 25 pounds, use standard office equipment and technology, and work effectively under pressure while managing multiple priorities.

Requirements

• Bachelor's degree or equivalent relevant formal academic or vocational qualification.
• Experience comparable to at least two years, 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 and attention to detail.
• Ability to manage time, remain focused, and 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 and provide clear, concise feedback or documentation of results.
• Ability to work collaboratively and efficiently in a remote capacity.
• Ability to communicate, receive, and understand information and ideas with diverse groups in a comprehensible and reasonable manner.
• Ability to use and learn standard office equipment and technology proficiently.
• Ability to work successfully under pressure while prioritizing and handling multiple projects or activities.
• Legal authorization to work in the United States without sponsorship.
• Ability to pass a comprehensive background check, including drug screening.
• Ability to work upright and stationary and/or standing for typical working hours, and lift and move objects up to 25 pounds.

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 data, and accuracy of final reported results.
• Communicate with laboratory staff to proactively maintain the quality of laboratory documentation.
• Deliver clear and concise findings identifying deficiencies in analytical data or reports.
• Escalate significant deficiencies to the project leader or supervisor for assessment.
• Facilitate conversations with laboratory staff about best documentation 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