JOB OBJECTIVE: The QA Systems Associate is responsible for supporting Quality System Document Control and Training activities at the Promega Madison location under direct supervision. This role builds foundational knowledge of eQMS platforms, controlled document workflows, training administration, and regulatory compliance requirements, while developing toward independent QS Reviewer accountability and eQMS system proficiency. This role will participate in the continual evaluation of routine document control and training tasks for tool-assisted or automated execution.

CORE DUTIES:

1. Support document control activities within eQMS, including routing documents for review and approval, processing change orders, and maintaining controlled document records under supervisor guidance.

2. Assist with training administration tasks including scheduling, tracking completion, maintaining training records, and updating training assignments in the eQMS system.

3. Process training determination forms, training assignment requests, employee updates, and leave-of-absence records in eQMS as directed.

4. Support audit preparation activities including pulling training records, organizing audit documentation, and assisting with audit room staging under the direction of senior team members.

5. Participate in eQMS configuration testing and workflow validation activities, developing foundational knowledge of how controlled procedures are encoded into validated system workflows.

6. Work toward meeting the requirements for a qualified independent QS Reviewer, including participation in document review activities with oversight from Supervisor.

7. Support evaluation of document control and training task types to identify candidates for automation or tool-assisted execution, under the direction of Supervisor.

8. Assist in the review and processing of obsolescence requests, administrative changes, and controlled copy creation and distribution.

9. Provide support to QA/RA and other departments in quality system improvement activities, as assigned.

10. Develop familiarity with 21 CFR Part 11 electronic records and signature requirements as they apply to eQMS workflows.

11. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

12. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.

13. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Associate or Bachelor's degree, or equivalent work experience that demonstrates readiness for success in this role.

2. 0–3 years of experience with compliance in document control and training, especially in a medical device or regulated business.

3. Basic understanding of Quality System processes and the importance of document control and training compliance in a regulated environment.

4. Strong attention to detail with the ability to follow controlled procedures accurately and consistently.

5. Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively under supervision.

6. Comfort learning new software platforms; prior experience with an eQMS (EtQ, MasterControl, or similar) is a plus but not required.

7. Demonstrated curiosity and aptitude for applying AI and automation tools to workflow problems, including ability to analyze a task and identify whether it is a candidate for tool-assisted execution.

8. Demonstrated proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with the ability to adapt and leverage emerging technologies, such as artificial intelligence, to improve efficiency, automation, and collaboration.

PREFERRED QUALIFICATIONS:

1. Prior experience in document control, training coordination, or quality systems support role in a medical device, biotech, or regulated manufacturing environment.

2. Familiarity with eQMS platforms such as EtQ or MasterControl.

3. Multilingual skills are a benefit.

PHYSICAL DEMANDS:

1. Ability to remain stationary for several hours at a time.

2. Ability to use a computer and Microsoft Office applications.

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.