Quality Operations Specialist

Thermo Fisher Scientific•Pittsburgh, PA

1d•Onsite

About The Position

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. 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.

Requirements

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.

Responsibilities

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).