Quality Operations Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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).

REQUIREMENTS

Keys to Success:

Education:

* Bachelor's degree in a technical discipline or comparable degree preferred.

* 2 or more years of related experience preferred.

Experience:

* 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.

Knowledge, Skills, Abilities:

* 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.

BENEFITS

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.