Data Reviewer, Biosafety – GMP

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

📋 Description

• Conduct reviews of both routine and complex analytical experiments involving pharmaceutical and biopharmaceutical substances.

• Assess laboratory data for adherence to analytical methodologies, client requirements, SOPs, GLP, GMP, and acceptance standards.

• Analyze sample results for scientific validity, completeness, accurate data representation, and final reported outcomes.

• Examine data entered into databases and reports while overseeing the quality of laboratory data.

• Collaborate with laboratory personnel to ensure the integrity of laboratory documentation.

• Provide clear and succinct review findings that highlight deficiencies in analytical data or reports.

• Report significant deficiencies to the project leader or supervisor.

• Lead discussions with laboratory personnel regarding documentation practices and quality observations.

• Champion quality and advocate for changes in the review process.

• Recognize and support initiatives for process improvements.

• Undertake additional tasks as assigned.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant academic/vocational qualification.

• A minimum of 2 years of relevant experience, or a suitable combination of education, training, and experience.

• Prior experience with formal data review in a GMP laboratory is highly preferred.

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

• In-depth understanding of chromatography may be necessary.

• Strong technical proficiency in laboratory procedures, methodologies, and standards.

• Excellent verbal and written communication abilities.

• Exceptional attention to detail.

• Capability to train staff on fundamental review techniques.

• Proficiency in independently reviewing laboratory reports and analytical methodologies.

• Ability to work effectively in a remote setting.

• Must be legally authorized to work in the United States without sponsorship.

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

• Capable of lifting and moving objects weighing up to 25 pounds.

• Proficient in using standard office equipment and technology.

• Ability to remain upright and stationary or standing for standard working hours.

• Adaptability to work in non-traditional environments.

• Capacity to perform effectively under pressure while managing multiple projects or activities.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Resources and support for career development.

• Accessibility assistance or accommodations during the application process.

• Equal employment opportunity and affirmative action protections.