Sr Application Analyst - QMS/MES
Listed on 2026-02-07
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IT/Tech
Data Analyst, Data Security
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.
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.
HOW WE WORKYou ll manage your own work while collaborating closely with the team—sharing knowledge, supporting peers, and communicating clearly with both technical and non-technical stakeholders. We expect adaptability when priorities shift and a commitment to Promega s culture: inclusion, respect, and emotional and social intelligence in how we treat each other. You ll need to understand and follow the ethical, legal, and regulatory requirements that govern our business.
COREDUTIES
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).
Build/support data exchanges using platform APIs (authentication, endpoints, payloads, throttling, and error handling). Operate within or near industry standard integration middleware.
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.
Maintain dashboards using platform analytics and reporting tools; support downstream embedding and access management.
Configure and troubleshoot SAML-based SSO (IdP/SP metadata, claims, and certs), especially in Microsoft Entra .
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.
Investigate issues across stack. Assist with change control, rollback, and documentation processes.
Support end-user onboarding, build reports/metrics, and assist with rollout and adoption of QMS/MES solutions.
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