Data Integrity Project Analyst

TEKsystems•Durham, NC

5d•$32 - $52•Onsite

About The Position

This role focuses on assisting with project coordination and authoring documentation for IT data integrity strengthening projects. Key responsibilities include managing projects like Acronis implementation for data backups and recovery, software upgrades for manufacturing and QC equipment, execution of audit trail and user access reviews, and implementing secured USB access control. The analyst will collaborate with various stakeholders to deploy robust data integrity controls and support GxP Change Management activities. This includes ensuring controlled qualification and deployment of IT system changes, record reviews, approvals, and completion of supporting documentation. The role also involves serving as a Subject Matter Expert (SME) on Quality Management System (QMS) records such as change controls, continuous improvements, and Corrective and Preventive Actions (CAPAs) related to computerized systems and data integrity. Additionally, the analyst will be responsible for the authoring and lifecycle management of IT Standard Operating Procedures (SOPs) and Work Instructions.

Requirements

Bachelors Degree or equivalent certifications in Information Technology or a related field.
3+ years of pharmaceutical industry IT experience.
Working knowledge of Computer System Validation (CSV), Data Integrity principles, and regulatory requirements for computerized systems, including 21 CFR Part 11 and EU Annex 11.
Experience with Quality Systems such as Veeva for document authoring and Quality Management (Change Controls, Deviations, CAPAs).
Strong attention to detail and a Quality mindset with commitment to accuracy and compliance.
Excellent communication and interpersonal skills, fostering collaboration and building strong relationships with internal and external stakeholders.
Project management skills with the ability to prioritize tasks, manage deadlines, and track progress effectively.
Ability to work independently, prioritize competing activities, and maintain compliance under tight timelines.

Nice To Haves

Relevant experience working with laboratory/manufacturing equipment such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV.
Relevant experience with instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, Hamilton, BacT with MYLA software, or other similar laboratory instruments.

Responsibilities

Assist with project coordination and authoring of documentation for IT data integrity strengthening projects.
Manage Acronis implementation and qualification for data backups and recovery.
Oversee manufacturing & QC equipment software upgrades and/or implementation of additional software controls.
Execute audit trail and user access review processes.
Implement secured USB access control process.
Collaborate with IT system owners, business systems owners, validation, and product quality to deploy robust data integrity controls across systems and processes.
Support GxP Change Management activities to ensure controlled qualification and deployment of IT system changes, record reviews, approvals, and completion of supporting documentation.
Serve as SME on QMS records including change controls, continuous improvements, and CAPAs associated with computerized systems and data integrity.
Author and manage the lifecycle of IT SOPs and Work Instructions.