Data Reviewer

This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applications from all locations within the US. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening.

About the role

The Data Reviewer performs review of a variety of routine and complex analytical analysis experiments conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices. Ensures analyses follow validated or experimental analytical procedures and compares results to methodology, protocol, product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). Reviews data entered into databases and reports, monitors the quality of laboratory data, and possesses a thorough understanding of laboratory procedures to conduct complex analysis review independently.

Responsibilities

• Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs.
• Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results.
• Communicates with laboratory staff to proactively maintain the quality of laboratory documentation.
• Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner.
• Escalates significant deficiencies to the project leader or supervisor for assessment.
• Facilitates 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.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience comparable to 2+ years, 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.
• Must demonstrate behaviors aligned with the 4i Values of Thermo Fisher Scientific.

Skills

• Strong technical knowledge, including 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 deal with multiple and changing priorities.
• Ability to provide clear and concise feedback and/or documentation of results.
• Ability to work in a collaborative team environment.
• Ability to work efficiently in a remote capacity.

Schedule

Standard (Mon-Fri)

Work Environment

• Able to communicate, receive, and understand information with diverse groups of people.
• 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.