GxP Quality Systems Associate (Documentation & Training)

ORIC Pharmaceuticals, Inc.; San Diego (CA); Hybrid; USD 34,000 - 45,000; Full time

Job summary

ORIC Pharmaceuticals, Inc. is seeking a Quality Systems Associate to support document control, training, and quality systems activities at our San Diego site.

You will work with QA, Technical Operations, Clinical, Regulatory and external Contract organizations to ensure timely, accurate documentation and compliance. The role emphasizes processing, review, and release of regulated GxP documents, coordination of training, and collaboration on continuous improvement of policies and SOPs.

Qualifications

• 0-2 years of relevant experience in Quality Assurance or experience in an academic or regulated environment.
• Highly polished writing and editing skills.
• High degree of proficiency in Microsoft Office Suite.
• Knowledge of GMP regulations and guidance documents is preferred, including but not limited to 21 CFR Parts 11, 210, 211; ICH GMP; EU EudraLex Volume 4.
• Experience with electronic quality management systems such as Veeva or MasterControl is a plus.
• Demonstrated ability to work independently in a collaborative, fast-paced team environment.

Responsibilities

• Support document processing, review and release of regulated GxP documents.
• Collaborate with document owners to resolve documentation discrepancies.
• Organize review and support activities to meet pre-established timelines.
• Participate in cross functional program meetings to provide QA updates.
• Maintain and update electronic quality systems, documentation files and folders per SOPs.
• Facilitate GMP training for internal employees/departments as required.
• Identify and drive continuous improvement of internal Policies, SOPs and Work Instructions.
• Provide document support for internal audits and regulatory inspections.

Skills

GxP document control

Microsoft Office

Written communication

Tools

Veeva

MasterControl

Job description

ORIC Pharmaceuticals, Inc. is seeking a Quality Systems Associate to support document control, training, and quality systems activities at our San Diego site.

You will work with QA, Technical Operations, Clinical, Regulatory and external Contract organizations to ensure timely, accurate documentation and compliance. The role emphasizes processing, review, and release of regulated GxP documents, coordination of training, and collaboration on continuous improvement of policies and SOPs.