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 and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

Customer Channels Group (CCG); RSD NA / HMD; Pittsburgh, PA

Discover Impactful Work:

As a Customer Quality Operations Specialist, you'll be working with customers, suppliers, and internal teams to ensure SKU accuracy and product quality in order to meet FDA current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) standards.

A day in the Life:

Collaborate in the product lifecycle to maintain product quality.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.Investigate quality issues with suppliers and support PPS strategies.Collect and analyze data to advise business decisions related to SKU performance, product quality, and PPS objectives.Develop and update Customer Quality Operations procedures and work instructions.Manage product certificates and change notifications inventory.Grow your expertise in ISO, 21 CFR, FDA current Good Manufacturing Practices (cGMP), and/or Good Distribution Practices (GDP) to recommend and implement process improvements.Scale processes and tools required to meet accelerated requirements of PPS and GDP Distribution Centers.Support internal audits of the Quality Management System (QMS).Participate in continuous improvement of core processes using Practical Process Improvement (PPI).

Keys to Success:

Education

- Bachelor’s Degree - Technical or comparable degree with 2 or more years of related experience preferred.

Experience

Experience supporting diverse product portfolios in a retail market.Proven experience partnering with suppliers preferred.Customer-facing engagement and/or customer service skills preferred.Experience in an ISO 9001 (or 13485, a plus), FDA cGMP environment, and/or GDP preferred.

Knowledge, Skills, Abilities

Adaptable to various technologies including Mainframe, Cloud-Based solutions, and database technology.Excellent interpersonal skills with a basic understanding of laboratory, sales, and quality terms.Ability to handle confidential information with discretion and maintain customer relationships.Ability to work both independently and as part of a team.Self-motivated and ambitious with a desire to learn.Attention to detail, well-organized, and strong time management and prioritization skills.

Benefits

We offer competitive remuneration, an annual incentive plan bonus, 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!