Sr Application Analyst - QMS/MES

Promega•Madison, WI

About The Position

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.

Requirements

Associate degree or equivalent work experience.
5-7 years of relevant experience in an engineering or technical role.
Proficiency in configuring QMS platform modules with roles, workflows, routes, and audit trails.
Familiarity with MES elements like digital work instructions, EBR/eDHR content, and training enforcement.
Working knowledge of API integrations and post-deployment troubleshooting.
Demonstrated ability to support validation activities and operational documentation.
Proven ability to manage tasks independently while contributing to a team.
Strong interpersonal and communication skills.
Proficient in operating a computer and phone, using Microsoft Office applications, and adapting to emerging technologies relevant to the role.
Ability to remain stationary for several hours at a time.
Ability to use a computer / Microsoft Office applications.

Nice To Haves

Experience with MasterControl (Qx and/or Mx modules) highly preferred.
Experience with other QMS/MES platforms such as Veeva Vault Quality, ETQ Reliance, Trackwise, SAP QM, Arena, or similar.
Experience with platform APIs, XML/JSON payloads, and Postman or similar tools.
Experience with SSO and access control in regulated environments.
SQL proficiency for reporting joins and light scripting in Python or PowerShell.
Exposure to SAP ERP, LIMS, MES, CRM, or PDM systems.
Experience working in collaborative, cross-functional environments.
Demonstrated openness to feedback and growth.
Familiarity with project tracking or task management tools.

Responsibilities

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 ID environments.
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.
Module Configuration & Support: Configure and operate QMS modules (Document Control, Change Control, Training, Audit, Risk, and Quality Event Management) and MES capabilities (electronic batch records, digital work instructions, recipe/variant authoring).
API Integration: Build/support data exchanges using platform APIs (authentication, endpoints, payloads, throttling, and error handling). Operate within or near industry standard integration middleware.
Two-Way System Flows: Help implement triggers/actions between QMS/MES platforms and enterprise systems such as ERP (business operations), LIMS (lab testing), CRM (customer interactions), and PDM (product design) so that quality events, production data, and customer feedback are automatically linked. Ensure data alignment and record reconciliation.
Dashboarding & Reporting: Maintain dashboards using platform analytics and reporting tools; support downstream embedding and access management.
SSO & Access: Configure and troubleshoot SAML-based SSO (IdP/SP metadata, claims, and certs), especially in Microsoft Entra ID environments.
Validation & Release Support: Execute validation deliverables (IQ/OQ/PQ); support release cycles using vendor validation accelerators or standard validation approaches. Understand 21 CFR Part 11 and EU Annex 11 expectations.
Troubleshooting & Support: Investigate issues across stack. Assist with change control, rollback, and documentation processes.
Training & Rollout Support: Support end-user onboarding, build reports/metrics, and assist with rollout 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 their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
Embracing and being open to incorporating 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.