QA - Data Integrity Consultant

Job Description
Our client, a world leader in diagnostics and life sciences, is looking for a "QA - Data Integrity Consultant" based out of San Diego, CA.

Job Duration: Long Term Contract (Possibility Of Further Extension)

Pay Rate: $85/hr on W2

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

Job Description:

We are seeking an experienced Senior Data Integrity Consultant (GxP) to support and enhance Quality Systems at our clinical-stage biopharmaceutical facility. This role will focus on maintaining and improving the Quality Management System (QMS) , Electronic Document Management Systems (EDMS) , and overall data integrity processes in a regulated environment.

The consultant will collaborate with cross-functional teams including QA, QC, Manufacturing, Validation, Supply Chain, and Clinical Operations to ensure compliance with **Good Manufacturing Practice and other GxP regulations while supporting operational quality processes.

• Support and maintain Quality Systems including Change Control, Deviations, CAPA, Training, and Document Control .

• Provide QA oversight for document management and legacy quality systems during system integration and migration.
• Manage and maintain GxP documentation within EDMS platforms such as Qualio and training systems such as ComplianceWire .
• Monitor and report quality metrics, ensuring timely closure of quality records and compliance with internal procedures.
• Assist in the development, revision, and management of SOPs, policies, and controlled documents.
• Support internal and external audits and contribute to corrective and preventive action plans.
• Deliver training on Quality System topics including GMP, Change Control, Deviations, and CAPA processes.
• Collaborate with cross-functional teams to promote data integrity, compliance, and continuous improvement.

Qualification :

Education:

Bachelor's degree in Life Sciences or related discipline.

Experience:

• 8+ years of experience in a GxP-regulated pharmaceutical or biotechnology environment .
• Strong experience with Quality Management Systems (QMS) and quality processes.
• Hands-on experience with EDMS and LMS platforms .
• Experience supporting audits, compliance activities, and SOP managementTechnical Skills

• Strong knowledge of **Good Manufacturing Practice / GxP quality systems
• Experience with Change Control, Deviations, CAPA, and Document Control
• Experience using Qualio and ComplianceWire

If interested, please send us your updated resume at

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Skill Set
21 CFR, QMS, CAPA. Data Integrity