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Validation Engineer I
Ref No.: 18-10839
Location: La Jolla, California
Quality Systems and Compliance Coordinator
La Jolla, CA
6+ Month Contract

This position provides support and coordination of critical quality and compliance systems for Global Operations R&D, California (GORDCA).

The major duties and responsibilities include, but are not limited to:

• Responsible and accountable for a wide range of tasks attributable to quality systems and other Global Operations compliance systems.
• Coordinate operations compliance/quality support for regulated spaces within GORDCA, including vendor oversight and compliance verification.
• Provide support and oversight of IQ/OQ performed on regulated laboratory equipment.
• Maintain quality and compliance standards and ensure proper completion of associated duties.
• Track regulatory and compliance inspections and audits.
• Provide support and participation for AAALAC site visits.
• Assist as a departmental trainer on various compliance and risk management systems.
• Support the GORDCA data integrity program.
• Assist in GDMS document management including drafting and formatting of SOPs and SOIs.
• Support operations compliance via document management, recordkeeping, inspection readiness, electronic training, upkeep, etc.
• Interface with GORDCA Call Center to support compliance and quality.
• Act as the GORDCA designee to the GOA Validation and Compliance Team (optional).

What is the minimum education experience required?: • Training and/or education in GxP and USDA regulation requirements.
• Training and/or education in quality management systems.
• Training and/or education in auditing

HS Diploma with at least 3 years exp
Associate's with at least 2 years exp
Bachelors with at least 1 years exp