Metrologist

At Roche, we are passionate about transforming patients' lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams representing various backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

The Metrologist supports the organization in maintaining compliance with established quality assurance standards for calibration through preparation, testing, and ongoing monitoring.

Performs calibration activities and evaluates internal controls, communications, and documentation to ensure compliance with internal policies and external safety, quality, and regulatory requirements.

Identifies and assesses deficiencies, failures, or risks, and collaborates with internal teams to implement effective corrective actions.

Coordinates and manages calibration processes, including scheduling, reviewing technical data, approving work records, and evaluating internal controls.

Prepares metrology related investigations, reports, summaries, and data analyses.

Utilizes advanced expertise to complete assignments with sound judgment and initiative. Acts as the subject matter expert (SME) for calibration activities. Understands the broader impact of work, offering strategic recommendations for effective solutions. Takes ownership of maintaining and continuously enhancing the quality system to ensure the achievement of quality objectives through proactive daily actions.

• Develop calibration methods and techniques based on measurement science principles, accuracy and precision requirements, and technical analysis of measurement problems.

• Calibrate instruments; troubleshoot, install, and repair mechanical components and electrical apparatuses.

• Identify measurement errors and root causes to ensure measurement accuracy.

• Serve as a Subject Matter Expert (SME) in metrology and provide technical support in troubleshooting, design, capital, and process improvement projects.

• Maintain and manage calibration supplies to ensure lab readiness.

• Review and process calibration documentation in compliance with Good Documentation Practices (GDP) and internal quality standards.

• Manage calibration data in the Maintenance Asset Management Software.

• Review and approve Out of Calibration Reports (OCRs) and calibration work records.

• Process and onboard new equipment into the asset management system.

• Perform technical data reviews to ensure conformance with quality specifications and standards.

• Conduct audits and risk assessments; evaluate internal controls, communication processes, and risk mitigation strategies.

• Ensure ongoing compliance with internal/external safety, regulatory, and quality standards through periodic documentation reviews.

• Identify risks, evaluate deficiencies, and collaborate with internal departments to implement corrective actions.

• Schedule and coordinate internal calibration activities and repairs.

• Collaborate with stakeholders and equipment owners to ensure resource availability for calibration and project execution.

• Perform administrative tasks related to calibration support functions.

• Bachelor's or Associate's degree in a technical field preferred

• Military service in calibration field highly regarded

• One year of metrology review and/or quality documentation review preferred

• Experienced and aware of ISO 9000 and/or ISO 17025 quality assurance program desired

• Bachelor's Degree or equivalent training, and specific knowledge and training in software applications

• 5 years of related experience

• Specific knowledge of the concepts of the calibration of manufacturing and laboratory inspection, measurement and testing equipment. (7-10 years' experience in a manufacturing, laboratory, R&D, or quality environment

• Knowledge of basic statistical tools and control concepts and methodologies. (i.e. control charts, limits, range, accuracy, specs, standards, etc.)

• Knowledge of quality systems and regulatory requirements (ISO and FDA) as related to calibration activities

• Experience with Regulatory Asset Manager (RAM) software e.g. BlueMountain, SAP