Quality Systems Associate: Document Control & Training

ORIC Pharmaceuticals; San Diego (CA); On-site; USD 71,635,000 - 95,991,000; Full time

Job summary

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company based in San Diego seeking a Quality Systems Associate to support document control, training, and quality systems activities. You will collaborate with QA, Regulatory and external partners to ensure compliant documentation and timely task completion.

Ideal candidates have 0–2 years in QA or regulated settings, strong writing skills, and proficiency with Microsoft Office; familiarity with GMP guidelines and electronic quality

Qualifications

• 0–2 years in QA or regulated academic setting.
• Strong writing and editing skills.
• Proficient in Microsoft Office.
• Familiarity with GMP and regulatory guidelines preferred (21 CFR 11/210/211; ICH GMP; EU EudraLex V4).
• Experience with electronic quality systems a plus (Veeva/MasterControl).

Responsibilities

• Support document processing, review and release of regulated GxP documents.
• Collaborate with document owners to resolve discrepancies identified during review.
• 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 and documentation files.
• 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.
• Perform all duties in keeping with ORIC’s core values and applicable regulations.

Skills

Quality Assurance

GxP knowledge

Documentation

Writing

Communication

Independent work

Time management

Cross-functional

Teamwork

Tools

Microsoft Office

Veeva

MasterControl

Job description

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company based in San Diego seeking a Quality Systems Associate to support document control, training, and quality systems activities. You will collaborate with QA, Regulatory and external partners to ensure compliant documentation and timely task completion.

Ideal candidates have 0–2 years in QA or regulated settings, strong writing skills, and proficiency with Microsoft Office; familiarity with GMP guidelines and electronic quality