Data Reviewer, Biosafety (GMP)

Thermo Fisher Scientific • Middleton, WI

2d • Remote

About The Position

The Data Reviewer in the Biosafety department reviews routine and complex analytical experiments involving pharmaceutical and biopharmaceutical compounds in various formulations and biological matrices. The role ensures analyses follow validated or experimental analytical procedures and that results comply with methodology, protocols, product specifications, SOP acceptance criteria, and GMP requirements. The reviewer checks data entered into databases and reports and monitors laboratory data quality. The position requires a thorough understanding of laboratory procedures and the ability to independently review complex analyses.

This is a full-time, fully remote role supporting a GMP laboratory in Middleton, Wisconsin. Applicants may be located anywhere in the United States and must be legally authorized to work in the United States without sponsorship. A comprehensive background check, including drug screening, is required. The role may involve exposure to potentially hazardous elements, including infectious agents typically found in healthcare or laboratory environments.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ 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.
• 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 communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• 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 use and learn standard office equipment and technology proficiently.
• Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Must be legally authorized to work in the United States without sponsorship and able to 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 data, and final reported results.
• Communicate with laboratory staff to proactively maintain the quality of laboratory documentation.
• Deliver clear and concise review findings identifying deficiencies in analytical data or reports.
• Escalate significant deficiencies to the project leader or supervisor for assessment.
• Facilitate discussions 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