Senior QC IT System Analyst LIMS or Empower

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Position Overview

As a Senior QC IT System Analyst you will own day-to-day operations reliability and continuous improvement of QC IT applicationsparticularly LabWare LIMS and Waters Empower. Youll 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.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

Join FUJIFILM Biotechnologies and help make the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive - what we call Genki.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Make an impact where quality meets technology. Join 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.

What youll do

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.

Minimum qualification requirements Candidates must meet all of the following:

Bachelors degree in a related discipline (IT or Computer Science) is required OR a Masters 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.

Preferred requirements

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.

What youll bring

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.

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical dental vision and prescription drug coverage with the option of a Health Savings Account with company addition we offer an industry leading 401(k)savings plan insurance coverage employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time sick time and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

As part of any recruitment process FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. Theorganisationis committed to beingtransparent about how it collects and uses that dataand to meeting its data protection obligations and may share this as part of the global recruitment process with hiringmanagers in Europe and the United States.

This is a global position that will support all FUJIFILM Biotechnologies sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior IC

Position OverviewAs a Senior QC IT System Analyst you will own day-to-day operations reliability and continuous improvement of QC IT applicationsparticularly LabWare LIMS and Waters Empower. Youll serve as the primary site contact for vendors lead upgrades and releases ensure systems remain in a val...