Senior QC IT System Analyst - LIMS and Empower

Fujifilm•Morrisville, NC

1d•Onsite

About The Position

As a Senior QC IT System Analyst, you will own day-to-day operations, reliability, and continuous improvement of QC IT applications—particularly LabWare LIMS and Waters Empower. You’ll serve as the primary site contact for vendors, lead upgrades and releases, ensure systems remain in a validated state, and provide expert second-level support. You will guide up to three team members, collaborate across Quality, IT, and Manufacturing, and play a key role in audit/inspection readiness and GxP compliance. This is a hands-on, high-visibility role for a systems leader who thrives at the intersection of technology, quality, and operations. You will make an impact where quality meets technology, joining a high-performing team that keeps critical QC laboratory systems running flawlessly, drives continuous improvement, and upholds data integrity and compliance standards across a global biologics/pharmaceutical environment.

Requirements

Bachelor’s degree in a related discipline (IT or Computer Science) is required OR a Master’s degree with 2+ years of related experience.
5+ years of experience in the IT field and/or pharmaceutical industry.
5+ years of relevant experience demonstrating strong leadership capabilities in managing teams and projects.
4+ years experience managing people.
Proven experience designing, installing, and testing IT systems.
Proven experience administering LabWare LIMS and Waters Empower applications.
Pharmaceutical experience is required.
Proven experience working and/or managing IT projects.
Strong knowledge of operating and maintaining software in regulated environments; working knowledge of GxP/CSV, GAMP, cGMP, ALCOA+.
Familiarity with ITIL/ITSM frameworks and service operations.
Excellent analytical, troubleshooting, and problem-solving skills with a drive for simplification and continuous improvement.
Exceptional communication skills and fluency in English; ability to influence and collaborate across functions and sites.
High sense of responsibility, quality mindset, and ability to work autonomously on shared goals.
Willingness to learn and share knowledge; ability to develop and transfer technical expertise to peers and business users.

Nice To Haves

Experience with investigations and change management.
Experience in pharmaceutical/biological manufacturing operations.
Experience leading others in a pharmaceutical/biological manufacturing facility.
Additional relevant certifications (e.g., LabWare LIMS or Waters Empower Administration).
Experience working in QC and QA processes.

Responsibilities

Lead operations for LabWare LIMS and Waters Empower to ensure reliability, availability, security, and compliance (GxP/CSV, ALCOA+, cGMP).
Provide timely, expert second-level support; anticipate customer needs and maintain a robust knowledge base for first-level support.
Own incident, problem, change, configuration, and release management under ITIL/ITSM; document and refine IT processes for efficiency and audit readiness.
Plan and execute upgrades and patches using risk-based validation approaches; approve validation and IT QMS documentation.
Manage or contribute to projects (scope, schedule, budget) using best-practice project management.
Serve as primary site liaison to vendors (LabWare, Waters); manage SLAs, coordinate updates, and negotiate priorities that meet compliance and business needs.
Establish and monitor KPIs to drive performance and continuous improvement; report status and risks to senior leadership.
Lead and mentor up to 3 direct reports; foster a collaborative, high-performance culture and standardize best practices across sites where applicable.
Partner with QC, QA/ITQ, CSV/Validation, Cybersecurity, Manufacturing, and Global IT to align releases, validation scope, and change planning.
Represent QC IT in audits/inspections; provide authoritative responses and evidence.
Support additional QC applications added to the portfolio as needed.