Quality Systems Associate (Contract)

ORIC Pharmaceuticals Inc.

San Diego (CA)

On-site

USD 65,000 - 90,000

Full time

4 days ago
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Job summary

ORIC Pharmaceuticals Inc. is seeking a document control/QA support role to manage regulated GxP documents, ensuring timely review and release. You will collaborate with document owners to resolve discrepancies and support cross-functional QA updates.

Responsibilities include maintaining electronic quality systems, SOPs, and training coordination, while supporting audits and inspections and adhering to ORIC’s policies and regulatory requirements.

Qualifications

  • GxP documentation experience
  • Familiarity with QA processes
  • Experience with SOPs and Work Instructions

Responsibilities

  • Review, process, and release regulated GxP documents.
  • Coordinate with document owners to resolve discrepancies.
  • Organize review activities to meet established timelines.
  • Provide QA updates in cross-functional program meetings.
  • Maintain electronic quality systems and SOPs.
  • Coordinate GMP training for internal employees.
  • Support internal audits and regulatory inspections.
  • Uphold ORIC’s values, policies, and regulations.

Skills

GxP Documentation
Regulatory compliance
SOP management

Job description

  • Support document processing, review and release of regulated GxP documents .Collaborate closely with document owners to resolve any documentation discrepancies identified during review.
  • Organize review and support activities to ensure timely review and completion of documentation task to meet pre-established timelines.
  • Participate in cross functional program meetings to provide appropriate QA updates.
  • Maintain and update electronic quality systems, documentation files and folders in accordance with written SOPs.
  • Facilitate/coordinate GMP training for internal employees/departments as required.
  • Identify and facilitate continuous improvement of internal Policies, SOPs and Work Instructions, as needed.
  • Provide document support for internal audits and regulatory inspections, as needed.
  • Perform all duties in keeping with ORIC’s core values, policies and all applicable regulations.
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