Sr. Principal Scientist, Quality Control - Laboratory Informatics

Role Summary

Sr. Principal Scientist, Quality Control – Laboratory Informatics. Serves as a business representative for laboratory IT systems, mentoring peers in lab systems, and supporting regulatory audits, management review of the laboratory Quality System, laboratory metrics, and laboratory documentation.

Responsibilities

• Maintains a safe work environment, leads safety initiatives, and supports Health, Safety, and Environmental goals.
• Validates laboratory equipment and software systems; maintains the validated state of software-based computerized systems in the lab.
• Ensures data integrity within the QC laboratory.
• Leads deployment and upgrade of QC laboratory IT systems (e.g., Empower, NuGenesis, MODA, Labvantage).
• Builds relationships with Global Quality Laboratory Network and Global IT teams.
• Acts as business owner and SME for QC laboratory IT systems.
• Collects data and authors management review documents for the laboratory quality system.
• Oversees and supports continuous improvement of quality systems related to the QC lab.
• Applies quality principles, cGMP, and lab systems to develop and execute procedures, training, and practices.
• Improves quality systems by updating worksheets, lab execution system documentation, methods, and other lab documentation systems.
• Manages and supports audit and inspection activities for the laboratory.
• Manages methods in the QC Laboratory.
• Performs and mentors others in change control, analytical investigations, root cause investigations, and activity planning.
• Implements and complies with safety standards; develops training materials.

Qualifications

• Required: Bachelor's degree in science, engineering, pharmaceutical-related field, or equivalent experience.
• Required: Minimum 6 years in the pharmaceutical industry with QC and laboratory computer system experience.
• On-site presence required.

Skills

• Fluent in English; strong written and oral communication.
• Understanding of cGMP and regulatory expectations; experience in GMP production environments.
• Proficiency with computer systems including LIMS, Laboratory Execution Systems, chromatography systems, electronic lab notebooks, and Microsoft Office.
• Ability to work in a lab with PPE; LEAN experience; project management; problem-solving; technical writing; statistical tools.
• Strong documentation, interpersonal, and teamwork skills; ability to train and mentor others; root cause analysis and troubleshooting.
• Ability to operate or implement Lab IT systems including LIMS and automated LEX systems.

Education

• Bachelor's degree in a science, engineering, or pharmaceutical-related field (or equivalent experience).

Additional Requirements

• Primary location: Kenosha County, Wisconsin.
• Travel: Approximately 10%.