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Job Description

Location: Lebanon, IN – 100% onsite

Duration: 12-18 months

Description:

This contractor will focus on supporting incoming QC data management, sample and result tracking, and help the creation of paperless electronic lab notebook templates (ELN). The position will also manage the data related to the creation of the templates for execution and management of QC testing. The candidate will support lab operations by ensuring LIMS functions, data creation, verification, sampling plans, and site collection points.

The perfect candidate will have experience assisting the improvement of QA by creating and revising data loads worksheets, providing input, developing execution system documentation and methods, and maintaining lab documentation systems. The candidates should be familiar with COAs, COTs, stability reports, ELN, LIMS, and lab SOPs.

Skills and Background

8-10 years within pharma, GMP environment

Experience in QC laboratories, with experience as data administrator for laboratory IT systems, including master data configuration and end user processes

Demonstrate good understanding of the application of data integrity requirements in cGMP environments and systems (ALCOA+)

Technical writing skills, communication, and interpersonal skills

Previous experience with ELN or LIMS systems, as power user or data steward with data management responsibilities within this system

Additional Characteristics

Previous experience with ATMP or specifically gene therapy manufacturing or QC

Strong analytical problem-solving skills, learning agility, and attention to detail

Established track record for implementing process improvement initiatives

Knowledge of operations business processes, such as batch disposition, materials management, laboratory specifications and methods, and laboratory process flow

Demonstrate understanding of data dependencies to deliver successful system interfaces for LIMS. LIMS interfaces include but are not limited to: enterprise resource planning software, manufacturing execution system, other laboratory execution systems (e.g. MODA), and CoA rendering system