Quality Operations Specialist

Posted Yesterday
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Pittsburgh, PA, USA
In-Office
Junior
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role
Ensure product quality and supplier compliance across a large SKU portfolio by collaborating with suppliers and cross-functional teams. Manage complaints, returns, quarantines, recalls, change notifications, certificates, SOPs, and QMS audits. Analyze SKU performance, drive supplier corrective actions, maintain controlled documentation, and support continuous improvement and regulatory compliance (ISO, FDA cGMP, GDP).
Summary Generated by Built In

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.

Skills Required

  • Bachelor's degree in a technical discipline or comparable degree
  • 2 or more years of related experience
  • Experience supporting diverse product portfolios in retail or regulated market environments
  • Proven experience partnering with suppliers
  • Customer-facing engagement and/or customer service experience
  • Experience with ISO 9001/ISO 13485, FDA cGMP, and/or GDP environments
  • Laboratory, manufacturing, and/or regulated industry experience
  • Adaptability to technologies including mainframe systems, cloud-based solutions, databases, and Microsoft Power Platform
  • Ability to develop and maintain SOPs and Work Instructions and manage controlled documentation
  • Experience supporting internal audits of the Quality Management System (QMS)
  • Strong interpersonal and communication skills with understanding of laboratory, sales, and quality terminology
  • Strong organizational, multitasking, time management, prioritization, and problem-solving skills

Thermo Fisher Scientific Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Thermo Fisher Scientific and has not been reviewed or approved by Thermo Fisher Scientific.

  • Retirement Support Retirement programs include a strong company 401(k) match and an employee stock purchase plan that add meaningful long‑term value. Feedback suggests these features stand out among core financial benefits even when base pay feels average.
  • Healthcare Strength Health coverage offers multiple national medical options alongside dental and vision, with company‑paid life and disability coverage. This breadth is considered a solid foundation even if some costs may not be the lowest among peers.
  • Parental & Family Support Paid parental and caregiver leave, backup care, adoption assistance, and specialized family resources are available. Feedback suggests these supports are a notable plus for colleagues managing family and caregiving needs.

Thermo Fisher Scientific Insights

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The Company
HQ: Waltham, MA
100,000 Employees

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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