Sr Specialist 1, QC LIMS

Position Overview

The Sr. Specialist 1, QC LIMS supports the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The Sr. Specialist 1, QC LIMS configures, validates and provides ongoing maintenance within the LIMS platform. This role is expected to complete and review change requests, validate configurations, provide user support and troubleshoot as needed. This role is responsible for implementing approved configuration changes within the LIMS platform as outlined in controlled change management records. The role supports documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. This role ensures the LIMS system meets the requirements of the LIMS procedures. The Sr. Specialist 1, QC LIMS works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements

Job Description

What You’ll Do

• • Participates in the rollout of Labware Laboratory Information Management System (LIMS) v.8 go live for the site. This includes migration of static data, configuration, validation and working with colleagues to ensure successful setup of Labware LIMS v.8.• Collaborates with business subject matter experts to define and document new or revised LabWare requirements• Configures basic and advanced LabWare LIMS objects including, but not limited to: Specifications, Analyses, Batch Templates, Test list, QC samples, Calculations, Format Calculations and Various Templates (Stability, Sample Login, Standards and Reagents)• Executes qualification or verification testing to support final implementation of LabWare configuration additions/revisions• Maintains and, if necessary, repairs configuration objects within Labware LIMS• Supports in creating queries to support business requirements• Works within the change management system to update configurations for specifications, analyses and other static data within LIMS, as needed • Provides timely response and user support including troubleshooting applications, creating new configuration templates, and maintains change records in accordance with version control procedures• Provides LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA, AD and Manufacturing staff, as needed• Evaluates data generated and/or stored within the System to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed• Writes test scripts for new LIMS functionality and participate in the validation of new functionality releases• Develops and maintains process configurations in System based on end user procedures and requirements• Collaborates with the LIMS team, IT department, and LIMS users to ensure new functionality meets user requirements• Creates and revises supporting documentation for LIMS: SOPS, Work Instructions, Design Specifications, training materials• Supports the expansion of the LIMS platform through the preparation and execution of test scripts for system validation• Liaises with end-users in the Laboratory to ensure changes to configurations meet the needs of the end user• Revises or develop LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation• Performs other related duties as assigned

Basic Requirements

• B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 2+ years of experience
• 1-3 years’ experience working in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics)
• Previous experience with Labware LIMS development or other LIMS software development

Preferred Requirements

• MS degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 0 years’ experience
• Leadership aptitude is beneficial
• cGMP/ ICH/ FDA regulations with 21 CFR Part 11 and GAMP experience, preferred
• Trackwise System experience for at least 1 year or similar

Working Conditions & Physical Requirements

• Ability to sit for prolonged periods of time up to 240 minutes
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.  
• Ability to conduct work that includes moving objects up to 10 pounds

FDBN is an Equal Opportunity Employer. All qualified applicants