QC Laboratory Data Systems Specialist, Pharma

Onsite in Indianaolis, IN. Our client seeks a QC Laboratory Data Systems Specialist to support MODA, ELN, and SDMS at a new manufacturing facility operating under cGMP. The specialist will partner with QC SMEs to configure master data, develop ELN templates, and maintain compliant data lifecycle practices. The role will also drive reporting, support investigations and change controls, and collaborate with quality and IT stakeholders to improve system integration and workflows.

Due to client requirements, applicants must be willing and able to work on a W2 basis. For our W2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $60.00 to $70.00/hr w2.

JN -

• Manage and support QC laboratory systems including MODA, ELN, and SDMS in a compliant cGMP environment.
• Ensure systems operate in alignment with regulatory and company requirements, including data integrity principles.
• Support sample and result tracking for environmental monitoring and utilities data.
• Create, maintain, and verify MODA master data including specifications, sampling plans, sampling sites, test methods, and LIMS interface data.
• Manage ELN master data for equipment, reagents, consumables, reference standards, and test methods.
• Perform second-person verification of master data entries.
• Design, build, review, and maintain ELN templates to enable paperless QC operations.
• Manage timelines for ELN template creation, review, and approval while ensuring workflow and compliance alignment.
• Create, compile, track, and review QC data and metadata including sample results, COAs, COTs, environmental monitoring reports, trending reports, testing trackers, and deviation and change control data.
• Contribute to SOP development and updates and support deviation investigations and change controls.
• Identify and implement process improvements for laboratory systems and workflows.
• Partner with global quality and IT teams to support system integration and data connectivity.

• Experience in a Quality Control laboratory with strong knowledge of cGMP regulations and compliance requirements.
• Hands‑on experience as a data administrator for laboratory systems.
• Experience with MODA data configuration and master data management.
• Experience with data integrity principles (ALCOA+).
• Familiarity with environmental monitoring and sterility assurance requirements such as EU GMP Annex 1.
• Experience with ELN systems as a power user or data steward.
• Strong technical writing, communication, and interpersonal skills.
• Experience in ATMP or gene therapy manufacturing or QC (preferred).
• Experience with ELN platforms such as NuGenesis and template configuration (preferred).
• Familiarity with laboratory instrumentation such as particle counters like Climet (preferred).
• Experience with equipment qualification, validation, and computer system validation (CSV) (preferred).
• Knowledge of system integration and data dependencies for MODA (preferred).

None specified.