Job Description :
Title : Validation Engineer I
Location : La Jolla CA 92121
Duration : 18 Months
Actual Desired title: Quality Systems and Compliance Coordinator
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