Job Description

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you2019ll be supported in achieving your career goals.

How will you make an impact?
Responsible for maintaining the Quality Management System in a safe, quality and customer focused manner. This individual will act as an 201Con the floor201D subject matter expert within Quality Engineering Group to support the on-time release of products following Good Manufacturing Practices.

What will you do?

* Upholds departmental standards as required in a cGMP environment
* Aids in management of the site Quality Management System including change control (ECR/ECO), complaint handling, change control, internal auditing, management reviews, training, and manufacturing area support
* Provides reports and monitors investigation progress to ensure adherence to predetermined timelines
* Performs statistical analysis to analyze trends, and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support at the site level (e.g. yield improvements, CAPA, complaint and scrap reduction)
* Leads teams to conduct root cause analysis
* Trends and assesses data to track program effectiveness and proactively identify areas of risk
* Drive a culture of continuous improvement by employing Practical Process Improvement concepts
* Reports all non-compliance and support, engage in, and potentially lead teams assigned to making improvements.
* Provides feedback and coaching to operations team members on daily work tasks
* Multi-tasks efficiently in a high-paced environment
* Focuses on team objectives to meet customer expectations
* Supports training and cross-training efforts for team development

How will you get here?

* Bachelor2019s degree preferred.
* 3-5 years' of work experience in a direct Manufacturing environment.
* 3-5 years2019 experience in Quality Control or Quality Assurance
* Strong written, verbal, and organizational skills, and the ability to work independently with cross-functional teams.
* Demonstrable Root Cause Analysis and CAPA skills
* High degree of proficiency in writing protocols and reports.
* Ability to work in a high paced team environment, prioritize multiple workflows and projects.
* Excellent computer skills, display specific expertise in Excel
* Quality standards knowledge (e.g., 21 CFR Part 820 and ISO 13485), preferred.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.