Senior QA Scientist: NPD Quality Sign-Off & Compliance

Promega Corporation; Madison (WI); On-site; USD 90,000 - 125,000; Full time

Job summary

Promega Corporation seeks a QA Scientist 4 to own quality judgments behind product claims, providing sign-off across the new product development pipeline and making release, disposition, and risk decisions for both catalog and custom products.

The role emphasizes reviewing design control documentation, ensuring regulatory compliance, and collaborating with Manufacturing, Marketing, Regulatory Affairs, and R&D to uphold Promega's quality system before product launch.

Qualifications

• B.S. degree with 7+ years in quality control/assurance or manufacturing.

Responsibilities

• Review and approve design control documents with quality sign-off at NPD stages.
• Audit and approve batch records, QC protocols, and disposition of nonconforming products.
• Review and approve labels, technical bulletins, manuals, and COAs.
• Approve study designs and change plans for shelf life/product changes with multiple departments.
• Drive CAPA, investigations, and process validation to identify root causes.
• Develop and deliver training to grow technical depth of the team.
• Facilitate meetings, map processes, and SOP development to resolve issues.
• Represent Promega in support of technical sales and customer inquiries on quality issues.

Skills

Quality systems

Statistical concepts

Documentation writing

AI tools

MS Office

Cross-functional collaboration

Manufacturing experience

Education

B.S. degree in a relevant field

Tools

Word/Excel

Document control software

Job description

Promega Corporation seeks a QA Scientist 4 to own quality judgments behind product claims, providing sign-off across the new product development pipeline and making release, disposition, and risk decisions for both catalog and custom products.

The role emphasizes reviewing design control documentation, ensuring regulatory compliance, and collaborating with Manufacturing, Marketing, Regulatory Affairs, and R&D to uphold Promega's quality system before product launch.