Sr Application Analyst - QMS​/MES

Overview

WHY THIS ROLE
You'll own the systems that keep quality and manufacturing running at a biotechnology company. This means solving real integration puzzles—connecting QMS and MES platforms to ERP, LIMS, and other enterprise systems so data flows automatically and audit trails stay clean. You'll work across teams (QA/RA, IT, Operations) on problems that actually matter: compliance workflows, electronic batch records, validation, and reporting. If you like building things that work and making regulated environments less painful, this is that job.

WHAT YOU'LL DO

• Configure and maintain QMS modules (Document Control, Change Control, Training, Audit, Risk, Quality Events) and MES capabilities (electronic batch records, digital work instructions, recipe/variant authoring).
• Build and support API integrations—authentication, endpoints, payloads, error handling—using industry-standard middleware.
• Implement two-way data flows between QMS/MES platforms and enterprise systems (ERP, LIMS, CRM, PDM) to automate quality events, production data, and customer feedback linkages.
• Maintain dashboards and reporting using platform analytics tools; manage access and embedding for end users.
• Configure and troubleshoot SAML-based SSO, particularly in Microsoft Entra .
• Execute validation deliverables (IQ/OQ/PQ) and support release cycles with an understanding of 21 CFR Part 11 and EU Annex 11 requirements.
• Troubleshoot issues across the stack—platform, middleware, and connected systems—and support change control and documentation processes.
• Support end-user training, onboarding, and adoption of QMS/MES solutions.
• Develop and support technical solutions that align with team and organizational goals.
• Work independently to complete assigned tasks, while collaborating closely with team members.
• Demonstrate clear and respectful communication with technical and non-technical stakeholders.
• Manage time effectively to meet deadlines and prioritize work.
• Adapt to changes in priorities, workflows, and technologies with resilience.
• Share knowledge and support peer learning within the team.
• Demonstrate inclusion through words and actions and be accountable for a safe workspace; act with kindness, curiosity, and respect for others.
• Embrace Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.
• Understand and comply with ethical, legal and regulatory requirements applicable to our business.

At Promega, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.