When you're part of the team at Thermo Fisher Scientific, you'll 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 you'll be supported in achieving your career goals.
About the Division and Location
The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. We play an increasingly critical role to support our customers' needs for high-quality products, a stable supply chain, and robust mitigation strategies, like manufacturing redundancy. Our growing operation in Grand Island, NY plays a key role in our Cell Culture network.
How will you make an impact?
As a member of our growing Quality team in Grand Island, you'll drive planned and systematic activities implemented in a quality system so that quality requirements for products, processes, systems or equipment will be fulfilled. Those activities include the planning and development of processes, procedures and test plans in order to ensure that products manufactured meet internal, customer and regulatory requirements.
What will you do?
- Designs quality assurance programs and systems for product and/or process development, manufacturing and testing to ensure product quality and compliance with regulatory requirements.
- Leads teams, quality, R&D and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards.
- Works directly with customers on quality issues/complaints. Work on driving issue/complaint resolution
- Leads teams to conduct root cause analysis
- Performs analyze trends, 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)
- Interfaces with suppliers and vendors to help resolve complex quality issues (e.g., investigations, troubleshoots raw materials issues). Leads resolution of issues
- Leads projects of moderate scope (may be cross functional or involve multiple teams)
- Works on issues and is guided by expected outcomes
- Provides quality specific training and guidance to the organization (e.g. Six Sigma programs) to correctly identify, define, and quality problems early
How will you get here?
Education and Experience
- Bachelor's degree from accredited college/university or equivalent relevant experience. Preferred Science or Engineering Degree
- Minimum of 1 year of relevant experience in Medical device or Pharmaceutical industry
- A minimum of 1 year of demonstrated leadership experience preferred (e.g. leading/supervising a project or a team)
- Knowledge of compliance with quality standards (e.g., EU GMP, 21 CFR Part 210, 211, 820, ISO 13485, 9001)
- Knowledge of advanced quality tools, such as DOE (Design of Experiment) and SPC (Statistical Process Control)
- Familiar with Quality tools such as FMEA (Failure Mode Effect Analysis) and Risk Analysis
- Proficiency with Global Systems such as Trackwise, Agile and E1/SAP
- Proficiency with Change Control Notification and CAPA software programs.
- Demonstrated ability to use rigorous logic and methods to solve difficult problems and drive towards effective solutions
- Dedicated to meeting the expectations and requirements of internal and external customers
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.
To Apply, please click the following link: https://thermofisher.contacthr.com/75752663
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