Job Summary

About the company

Our partner develops amazing quality management software for the whole enterprise. Our cloud-based platform, which includes modules for Document Management, Issue/CAPA, Training, Audits and Supplier Management, offers companies the opportunity to improve quality compliance and save money.

Their business is built on an established and well-respected client base, and growing rapidly. We’ve been able to cultivate an environment that is both collegial and entrepreneurial, but still retains a bit of early-stage fun. Our headquarters is located in Narberth, PA.

Our partner develops amazing quality management software for the whole enterprise purpose-built for Life Sciences companies. Our cloud-based platform offers companies the opportunity to improve quality compliance and save money.
A sneak peek at the modules of our quality management system:

  • DOCUMENTS MODULE: Manage the full document lifecycle with every version from draft to retirement.
    • Utilize built-in Part 11/Annex 11 compliant electronic signatures
    • Automate and enforce workflows that match your current processes
    • Set access rights based on user roles/permissions
    • Query data, even within documents, with the Keyword Search feature
    • Collaborative editing with Microsoft Office for the web
  • TRAINING MODULE: Easily create, track, and complete training from SOP review to on-the-job events.
    • Author and enforce role-based training curriculum on the fly
    • Automate email reminders for new and interval training assignments
    • Produce detailed reporting by curricula, role, training item type, or individual
  • ISSUES MODULE: Build custom, closed-loop processes like CAPAs and Deviations for any event type.
    • Design multistage processes with custom electronic forms and workflows
    • Include stages for root cause analyses and effectiveness checks
    • Automate issue notifications and investigator assignments
    • Create dashboards to measure process throughput and activity
  • CHANGE CONTROL MODULE: Keep your finger on the pulse of changing processes.
    • Configure forms and stages to match your current processes
    • Assign granular permissions for access and escalation
    • Ensure timely follow-up by creating & managing sub-tasks for each stage
  • AUDITS MODULE: Streamline your entire GxP audit and supplier qualification process.
    • Call up and organize an approved vendor list
    • Set an evergreen audit calendar to update as you work
    • Establish a feedback loop for risk management with reports and trends

The business is built on an established and well-respected client base, and growing rapidly. We’ve been able to cultivate an environment that is both collegial and entrepreneurial, but still retains a bit of early-stage fun. Our headquarters is located in Ardmore, PA.


To be successful in this role you must:

  • Have excellent written and verbal communication skills and enjoy working in a transparent environment.
  • Have the self-discipline to achieve continuous improvement in your technical & professional skills and the ability to apply those skills through the enhancement of software development team processes.
  • Be comfortable working in a distributed team.
  • Have working knowledge and experience of distributed cloud architectures.
  • Test and adopt new technologies as they are introduced to the company and the software development domain.
  • Have extensive experience delivering working software in a complex SDLC using .NET / C#, JavaScript/Node.js, SQL, HTML, CSS.
  • Have working knowledge and experience of code management tooling and patterns.
  • Be comfortable giving and receiving technical-feedback and training through code review and ad-hoc processes.
  • Serve as a key stakeholder in infrastructure related incident response, especially when pertaining to data integrity.
  • Adhere to company’s core values
    • Be Kind: Honesty, transparency, and kindness fuels everything we do, from the way we interact with each other to the way we build our business and support our clients.
    • Keep it Simple:Nobody wants to add more complexity to their day. Whether we’re building software or guiding clients along their GxP journeys, we keep it simple.
    • Always be Improving:Continuous improvement isn’t just a buzzword. Every day we aim to be better for our employees, our community, and our customers.

Be Part of the Community: Together, we’re better. We’re intentional with our participation and support for the Quality community, as well as the communities in which we work and live.

Areas of Experience:

  • .NET / C#
  • React Development Tools
  • HTML
  • CSS
  • JavaScript / TypeScript
  • SQL
  • Git / GitHub

Requirements

  • B.S. in Computer Science or related area of study.
  • 8+ years in progressive, hands-on, software engineering roles.
  • 3+ years working with .NET / C#
  • 2+ years working with JavaScript, SQL, HTML, CSS
  • 1+ years working with TypeScript.
  • 3+ years working with AWS Cloud services.
  • Nice to have: Node.js experience
  • Demonstrable experience with relational databases, and a base understanding of data modeling
  • CEFR Level B2 or higher in English - comfort and familiarity with written and oral communications is necessary.
  • Hybrid SDLC process experience including a blend of waterfall and agile methodology.