What are the responsibilities and job description for the Quality Operations Specialist position at Thermo Fisher Scientific?
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion, we give our people the opportunities to make significant contributions to the world.
Location/Division Specific Information: Customer Channels Group (CCG); RSD NA / HMD; Pittsburgh, PA
Description
Discover Impactful Work:
As a Quality Operations Specialist, you will help ensure product quality and supplier compliance across a diverse portfolio of 4 million SKUs. This role collaborates closely with suppliers and cross-functional teams to support quality operations activities throughout the product lifecycle, including but not limited to new product introduction through quarantine of non-conforming products.
A Day in the Life:
Keys to Success:
Education:
We offer competitive remuneration, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides employment with an innovative, forward-thinking organization and outstanding career and development prospects. Our exciting company culture stands for integrity, intensity, involvement, and innovation.
Standard (Mon-Fri)
Environmental Conditions
Office
When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion, we give our people the opportunities to make significant contributions to the world.
Location/Division Specific Information: Customer Channels Group (CCG); RSD NA / HMD; Pittsburgh, PA
Description
Discover Impactful Work:
As a Quality Operations Specialist, you will help ensure product quality and supplier compliance across a diverse portfolio of 4 million SKUs. This role collaborates closely with suppliers and cross-functional teams to support quality operations activities throughout the product lifecycle, including but not limited to new product introduction through quarantine of non-conforming products.
A Day in the Life:
- Collaborate throughout the product lifecycle to maintain product quality and compliance.
- Work cross-functionally with departments such as Commercial Sales, Production Products and Services (PPS), Distribution Operations, Regulatory Affairs, Finance, and Supply Chain.
- Perform quality operations processes for the portfolio, including handling customer complaints, medical device returns, quarantines, recalls, and change notifications.
- Partner with and drive suppliers to complete the necessary actions required to ensure product quality, including product complaint investigations, timely change notifications, quarantine resolution, and accurate certificate documentation.
- Investigate quality issues with suppliers and support product category strategies.
- Collect and analyze data to support business decisions related to SKU performance and product quality.
- Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Manage product certificates and change notification document repositories, including publication and distribution of controlled documentation.
- Grow expertise in ISO standards, 21 CFR, FDA current Good Manufacturing Practices (cGMP), and/or Good Distribution Practices (GDP) to recommend and implement process improvements.
- Support internal audits of the Quality Management System (QMS).
- Participate in continuous improvement initiatives using Practical Process Improvement (PPI).
Keys to Success:
Education:
- Bachelor's degree in a technical discipline or comparable degree preferred.
- 2 or more years of related experience preferred.
- Experience supporting diverse product portfolios in a retail or regulated market environment.
- Proven experience partnering with suppliers.
- Customer-facing engagement and/or customer service experience.
- Experience in an ISO 9001 environment (ISO 13485 preferred), FDA cGMP environment, and/or GDP environment preferred.
- Laboratory, manufacturing, and/or regulated industry experience preferred.
- Adaptable to various technologies including mainframe systems, cloud-based solutions, databases, and Microsoft Power Platform applications.
- Ability to quickly learn and apply new technical systems and software tools.
- Excellent interpersonal and communication skills with a working understanding of laboratory, sales, and quality terminology.
- Ability to handle confidential information with discretion while maintaining strong customer and supplier relationships.
- Ability to work independently and collaboratively in a team environment.
- Strong organizational skills with the ability to manage multiple priorities simultaneously in a fast-paced environment.
- Demonstrated ability to multitask effectively while maintaining accuracy, attention to detail, and responsiveness under pressure.
- Self-motivated with a strong desire to learn and continuously improve.
- Strong time management, prioritization, and problem-solving capabilities.
We offer competitive remuneration, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides employment with an innovative, forward-thinking organization and outstanding career and development prospects. Our exciting company culture stands for integrity, intensity, involvement, and innovation.