Position Overview

The Senior Specialist II, QC LIMS is a site-level and cross-functional leader for the Laboratory Information Management System (LIMS), operating with minimal oversight and in accordance with applicable regulatory, corporate, and scientific standards. This role architects, configures, validates, and governs the LIMS platform; plans and executes complex change initiatives; establishes and monitors system health and data integrity controls; and leads continuous improvement and expansion of LIMS capabilities. The Senior Specialist II partners closely with Quality Control (QC), Analytical Development (AD), Manufacturing, Information Technology (IT), and Quality Assurance (QA) to ensure sustained compliance with Good Manufacturing Practice (GMP) requirements, robust data integrity, and business continuity.

Job Description

What You'll Do

• Leads LIMS release and major enhancement initiatives, including planning, risk assessment, migration strategy for static and master data, configuration build, validation approach, cutover, and hypercare to ensure successful site adoption of LabWare LIMS v.8.
• Serves as the primary configuration architect for complex LIMS objects, including Specifications, Analyses, Batch Templates, Test Lists, Quality Control samples, Calculations and Format Calculations, and advanced templates (for example, Stability, Sample Login, Standards and Reagents), ensuring scalability, maintainability, and compliance.
• Governs the site change management process for LIMS, including impact assessment, approval, prioritization, and implementation of configuration updates to specifications, analyses, and other static data, ensuring alignment with controlled records and version control practices.
• Establishes and maintain system data integrity controls and monitoring (for example, audit trails, access management, segregation of duties, and periodic reviews); investigate and remediate data integrity issues; drive preventive actions.
• Designs, develops, and optimizes advanced queries and reporting solutions that deliver actionable insights, enable trending and metrics, and identify process gaps; implement and steward key performance indicators for LIMS usage, turnaround time, and data quality.
• Provides expert-tier user support, root-cause analysis, and problem resolution; triage and resolve complex incidents; implement permanent corrective and preventive actions; communicate changes and system impacts to stakeholders.
• Leads cross-functional collaboration with QC, AD, QA, Manufacturing, and IT to translate business needs into user and functional requirements; facilitate design workshops; ensure delivered solutions meet user requirements and compliance expectations.
• Authors, reviews, and approves LIMS documentation, including Standard Operating Procedures, Work Instructions, Design and Configuration Specifications, training materials, validation protocols, and requirement specifications; ensure documentation accurately reflects production configurations.
• Develops and delivers role-based training curricula and job aids; mentor and coach Specialists and end-users; elevate overall system proficiency and stewardship across the laboratory organization.
• Maintains and enhances LIMS integrations and interfaces (for example, instruments, chromatography data systems, enterprise resource planning, stability systems, and data visualization tools) in partnership with IT and vendors; ensure interface reliability and validated state.
• Leads audit and inspection readiness for LIMS; present system design, controls, validation evidence, and change records to internal and external auditors; address observations with timely, effective corrective and preventive actions.
• Champions continuous improvement by evaluating new LIMS capabilities, automation opportunities, and process simplification; propose and lead projects that reduce manual effort, cycle time, and compliance risk.
• Performs other related duties as assigned.

Knowledge, Skills, and Abilities

• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point).
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Excellent verbal and written communication skills and attention to detail.
• Thorough understanding of the pharmaceutical/biotech testing.
• Proven ability to understand and implement data integrity standard and regulations.
• Proven ability to conduct investigations, writing deviations, and CAPA's.
• Superior technical writing and problem-solving skills required.
• The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

Minimum Qualifications

• S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience
• 5+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO).
• 1-3 years experience in a GMP environment.
• Previous experience with Labware LIMS development or other LIMS software development.

Preferred Qualifications

• Experience with LabWare LIMS V8.
• S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience.
• Experience with Customer Relationship Management.
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system).

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• Ability to discern audile cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc..
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

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 place. 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.

*LI-Onsite