QA Scientist

JOB REQUIREMENTS: Job Description OUR TEAM: The Product Quality and Compliance (PQ&C) team at Promega is a collaborative group of QA Scientists, Specialists, and leaders who support one another in assuring that our products reflect the highest quality standards for our customers. We partner across the business to uphold rigorous quality and regulatory expectations for Research Use Only (RUO), regulated In Vitro Diagnostic (IVD), and Active Pharmaceutical Ingredient (API) products. Our team combines scientific expertise with a strong commitment to compliance, and we take pride in an environment where curiosity, accountability, and teamwork help us deliver products our customers can trust every day. YOUR ROLE: Every product Promega ships carries a claim, a spec, a certificate of analysis someone stood behind - you'll be that someone. You'll review and approve the data, documentation, and quality decisions that determine whether a product is ready for market, working across catalog and custom products where the margin for error is thin and the standards are non-negotiable. A primary focus of this role is quality support for new product development: reviewing design control documentation and providing quality sign-off across the NPD pipeline so new products meet Promega's quality system and regulatory requirements before they ever launch. You'll have AI tools available to speed up research, documentation, and organizing investigation records, but the quality judgment calls - whether a result is disposition-worthy, whether a claim is defensible, whether a risk is acceptable - are yours to make. That's the core of the job. JOB OBJECTIVE: The QA Scientist 4 owns the quality judgment behind Promega's product claims, providing quality sign-off across the new product development pipeline and making release, disposition, and risk decisions for catalog and custom products. CORE DUTIES: 1. Reviews and approves design control documentation and provides quality sign-off at key stages of the NPD pipeline, catching quality and regulatory gaps during development instead of after launch. 2. Audits, reviews, and approves batch records, manufacturing and QC protocols, and nonconforming-product dispositions. 3. Reviews and approves labels, technical bulletins, technical manuals, and certificates of analysis. 4. Approves study designs and change plans for shelf life and product changes, in partnership with Manufacturing, Marketing, Regulatory Affairs, and R&D. 5. Drives CAPA, complaint investigations, and process validation, translating a customer or manufacturing problem into a resolved root cause. 6. Builds and delivers training in areas of expertise,... For full info follow application link. Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/B66AD330B2A44738 Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.