Job Details

  • Title: Quality Systems and Compliance Coordinator
  • Code: RCI-PFE-16842-1
  • Location: La Jolla California (CA) 92121
  • Posted Date: 10/10/2019
  • Duration: 18 Months
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  Job Description

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