Extractables and Leachables Data Reviewer

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

📋 Description

• Conduct routine and complex analytical assessments of pharmaceutical and biopharmaceutical compounds, formulations, and biological matrices.

• Ensure that analyses adhere to established or experimental analytical protocols.

• Compare outcomes with methodologies, protocols, product specifications, SOP acceptance criteria, and GMP standards.

• Review data entered into databases and associated reports.

• Oversee the quality of laboratory data.

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

• Evaluate sample results for scientific validity, completeness, accurate representation of data, and final reporting.

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

• Provide clear and concise reports on deficiencies in analytical data or documentation.

• Report significant deficiencies to project leaders or supervisors.

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

• Advocate for quality and propose changes to review processes.

• Identify and support initiatives for process improvement.

• Execute other assigned responsibilities.

⛳️ Requirements

• Must have legal authorization to work in the United States without the need for sponsorship.

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

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

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

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

• In-depth knowledge of SOPs and Federal Regulations, including GLP and GMP, is essential.

• Strong familiarity with chromatography may be necessary.

• Solid technical understanding of laboratory procedures, methodologies, and standards is required.

• Excellent verbal and written communication skills are essential.

• Strong attention to detail is required.

• Ability to manage time effectively and remain focused on achieving goals.

• Capability to train staff on basic review techniques.

• Ability to independently assess laboratory reports and analytical methodologies.

• Proficiency in managing multiple and shifting priorities.

• Capacity to provide clear and concise feedback and documentation of results.

• Ability to work collaboratively within a team environment.

• Aptitude for working efficiently in a remote setting.

• Skills in communicating, receiving, and understanding information and ideas with diverse groups.

• Capability to work upright and stationary and/or standing for typical working hours.

• Ability 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 effectively under pressure while prioritizing multiple projects or activities.

🏝️ Benefits

• Fully remote work option available.

• Standard work schedule from Monday to Friday.

• Accessibility services/accommodations for applicants with disabilities during the hiring process.