Quality Operations Specialist

Work Schedule

Environmental Conditions

Job Description

When youre part of the team at Thermo Fisher Scientific youll do important work. And youll 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 youll 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

- Bachelors 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!