Job Title: Lab Systems Specialist
We are seeking a skilled Lab Systems Specialist to support our Global Quality Control Operations. The successful candidate will be responsible for building and maintaining LIMS master data, ensuring compliance with testing standards for product release and stability.
Key Responsibilities:
* Create and maintain master/static data in lab digital systems following standards and change management processes.
* Execute and document change controls for Enterprise system applications.
* Collaborate with lab personnel to ensure accurate system setup for laboratory needs.
* Perform dry runs and gather lab user feedback on system changes/enhancements.
* Stay updated on system functionality to optimize lab operations.
* Participate in business process improvement/lean initiatives.
* Provide ad hoc system support for QC lab users.
* Author, revise, and review SOPs, WIs, and related training content.
* Communicate technical updates to team members and management.
* Support project teams and deliver assigned tasks.
Qualifications & Experience:
* Bachelor's degree in a scientific, computer, or engineering field with 1–3 years of biopharma experience (or equivalent).
* Basic understanding of analytical techniques (preferred).
* Experience with lab systems (LIMS, LES, Empower, MODA, CIMS) or databases/programming.
* Proficiency in Microsoft Office (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word).
* Knowledge of cGMPs, regulatory requirements, and industry best practices.
* Strong interpersonal, communication, problem-solving, and analytical skills.
* Ability to prioritize multiple projects and meet deadlines.
* Adaptable to changing business needs and able to work independently or in a team.