Thermo Fisher Scientific Validation Associate III in Greenville, North Carolina
When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
Provides direct quality support (e.g. compliance, regulatory assessment, validation) to the business unit, clients and corporate management. Facilitates activities/projects with moderate complexity, perform quality functions to ensure accurate and timely completion with frequent decision making required. Creates, reviews, approves, tracks and presents documents required for compliance with pharmaceutical regulations. Identifies areas of non-compliance and assist in the resolution of major issues. Performs activities across key quality functions as needed to ensure full support of business units.
Prepares, reviews and approves validation, hold, investigation and audit reports; gains multidisciplinary consensus; makes recommendations to management based on review and analysis of data.
Manages, schedules, executes and tracks multiple project activities of moderate complexity with multi-disciplinary departments to ensure timely completion of deliverables.
Analyzes data to determine trends, acceptability, identify deviations and assure resolution of deviations.
Conducts deviation investigations, such as validation failures, complaints and hold investigations. Identifies appropriate corrective actions.
Assesses impact of changes in systems, critical documentation, processes and suppliers.
Identifies critical parameters/processes and takes appropriate actions to ensure adequate controls are in place. Performs and assists with risk assessments for processes and systems.
Interacts during client and regulatory audits.
Leads audits and/or assists with regulatory audits.
Provides training in area of expertise within Validation.
Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Bachelor’s degree in related field is required.
Three years of relevant experience in Life Science, Chemistry, Biology, Engineering, Biomedical, or IT is preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Familiarity with the pharmaceutical industry or other regulated industry, proficient in the use of computerized office applications (e.g. Word, Excel), project management and demonstrated scientific writing skills.
Knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry expectations.
Outstanding attention to detail and organizational skills.
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