QA Scientist 4

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, growing the technical depth of the team over time.

7. Participates in process mapping and SOP development, and organizes or facilitates meetings to review findings and resolve planning and technical issues.

8. Represents Promega in support of technical sales at trade shows and exhibitions, and serves as a direct point of contact with customers on quality issues and questions.

KEY QUALIFICATIONS:

1. B.S. degree with a minimum of 7 years of relevant industry experience in quality control, quality assurance, or manufacturing.

2. Direct, hands-on experience applying quality assurance systems in a manufacturing, product development, or process development environment.

3. Working knowledge of basic statistical concepts applied to analytical data, process validation, and QA activities.

4. A track record of improving processes and writing procedures that actually get followed.

5. Comfortable using AI tools for literature and regulatory research, drafting and structuring documentation, and organizing investigation records, while retaining ownership of the underlying technical judgment.

6. Proficiency with standard word processing and spreadsheet software, and the ability to develop concise, clear, and accurate written communication.

7. Proven ability to work constructively with a broad range of people.

PREFERRED QUALIFICATIONS:

1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis, evidenced by peer-reviewed publications.

2. Work experience in quality assurance from a regulated industry, such as ISO 13485.

PHYSICAL DEMANDS:

1. Visual acuity for physical inspection of finished product, raw materials, and accompanying documentation.

2. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, protective gloves).

3. Ability to use computers in an interactive manner for extended periods of time.

4. Ability to move objects up to 20 pounds.

At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.