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
hr@dawarconsulting.com/kavitha@dawarconsulting.com Skill Set 21 CFR, QMS, CAPA. Data Integrity