Data Reviewer – GMP, Cell & Gene Therapy

This is a fully remote position, open to applicants in Wisconsin.

📋 Description

• Conduct routine and complex analytical analysis experiments related to pharmaceutical and biopharmaceutical compounds.

• Ensure that analyses adhere to either validated or experimental analytical procedures.

• Compare results against methodologies, protocols, product specifications, SOP acceptance criteria, and GMP standards.

• Review data submitted to databases and reports.

• Oversee the quality of laboratory data.

• Assess laboratory data for compliance with analytical methods, client requirements, and SOPs.

• Review sample results for scientific accuracy, completeness, data representation, and final reporting.

• Collaborate with laboratory personnel to uphold the quality of laboratory documentation.

• Deliver clear and concise review findings while identifying deficiencies in analytical data or reports.

• Escalate major deficiencies to the project leader or supervisor.

• Facilitate discussions with laboratory staff regarding documentation practices and quality issues.

• Advocate for enhancements in quality and review processes.

• Identify and support initiatives aimed at process improvement.

• Execute other assigned duties.

⛳️ Requirements

• Must possess legal authorization to work in the United States without requiring sponsorship.

• Must successfully complete a comprehensive background check, including a drug screening.

• Bachelor’s degree or equivalent formal academic/vocational qualification is required.

• A minimum of 2 years of relevant experience, or an equivalent combination of education, training, and experience.

• Prior experience with formal data review in a GMP lab is strongly preferred.

• Comprehensive knowledge of SOPs and Federal Regulations, including GLP and GMP, is essential.

• A strong understanding of chromatography may be required.

• Robust technical knowledge of laboratory procedures, methodologies, and standards.

• Excellent verbal and written communication skills.

• Exceptional attention to detail.

• Capability to train staff on basic review techniques.

• Ability to independently review laboratory reports and analytical methods.

• Proficiency in managing multiple and shifting priorities.

• Skilled in providing clear and concise feedback and documentation of results.

• Ability to work effectively in a remote setting.

• Competence in communicating, receiving, and comprehending information and ideas with diverse groups of individuals.

• Ability to maintain an upright and stationary position or stand for standard working hours.

• Capability to lift and move objects weighing up to 25 pounds.

• Flexibility to work in non-traditional environments.

• Proficiency in using and learning standard office equipment and technology.

• Ability to perform successfully under pressure while prioritizing and managing multiple projects or activities.

🏝️ Benefits

• Engage in meaningful work that supports health, cleaner, and safer outcomes.

• Access to resources that facilitate the achievement of individual career goals.

• Collaborate with a global team of over 100,000 colleagues.

• Receive accessibility assistance/accommodations during the application process.

• Work in an equal opportunity and affirmative action employment environment.