Promega Corporation · 2 hours ago
Sr Application Analyst - QMS/MES
Promega Corporation is a biotechnology company focused on quality and manufacturing solutions. The Sr Application Analyst will be responsible for integrating QMS and MES platforms with enterprise systems to ensure seamless data flow and compliance, while also supporting user training and system maintenance.
JournalismLife ScienceManufacturing
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
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
Qualification
Required
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
Preferred
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
Company
Promega Corporation
At Promega Corporation, creativity and connection drive discovery and innovation.
H1B Sponsorship
Promega Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown1984-12-01Series Unknown
Recent News
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