Senior Quality Control Specialist, LIMS

4 weeks ago


Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Overview

The Senior Quality Control Specialist, LIMS role is a critical position within Iovance Biotherapeutics Inc, responsible for the deployment and administration of the Quality Control Laboratory Information Management System (LIMS). This individual will play a key role in ensuring the effective management of QC functionality, including analytical and microbiology testing, environmental monitoring, raw materials, critical reagents, stability, and sample management, to support compliance with regulatory requirements and commitments for clinical and commercial products.

This role requires a strong understanding of LIMS within a cGMP-regulated environment and the ability to collaborate with stakeholders to develop requirements and a long-term vision for LIMS. The successful candidate will have experience with configuring and implementing a LIMS solution, as well as managing external partners for technical support activities.

Key Responsibilities
  • Execute change management in a GMP environment and drive changes through the appropriate quality system.
  • Support deviations and LIRs with LIMS information as needed.
  • Collaborate with stakeholders to develop requirements and the long-term vision for LIMS.
  • Drive development and implementation of the LIMS by partnering with IT and external vendors.
  • Develop and regularly update key project information, including status, timelines, scope statements, budgets, resources, risks, issues, decisions, and action items.
  • Manage enhancements, incident investigation, and changes for a multi-site, global LIMS.
  • Draft program-related support documents, including operational SOPs, Work Instructions, System Impact assessments, change controls, as needed.
  • Track and resolve LIMS support program issues and identify potential enhancements to the system.
  • Independently plan, manage, and execute assignments, contribute to project planning meetings.
  • Support product stability programs, including generation of stability protocols in LIMS, and support as needed accessing final reporting or trending of stability data.
Requirements
  • Bachelor's degree in a relevant discipline (biological sciences, computer science, or equivalent).
  • Minimum of 5-10 years of experience in a cGMP laboratory, including at least 3 years as a LIMS administrator. Experience with configuring and implementing a LIMS solution.
  • Experience with translating business documents (batch records, test methods, stability protocols) into technical requirements and configuring in a LIMS solution.
  • Ability to manage external partners with respect to technical support activities.
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
  • Problem solver who not only identifies issues but leads efforts to resolve them.


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