Senior Specialist 2, QC LIMS

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

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.

Requirements

B.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.
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.

Nice To Haves

Experience with LabWare LIMS V8.
B.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).

Responsibilities

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.