Quality Compliance Associate I/II — Equity Eligible

Capricor Therapeutics, Inc.; San Diego (CA); On-site; USD 70,000 - 82,000; Full time

Benefits offered by this job

Discretionary bonus

Equity incentives

Healthcare plan

401(k) with company match

Paid time off

Job summary

Capricor Therapeutics, Inc. in San Diego seeks an Audit/QA professional to lead internal audits of GxP processes, supplier audits, and CAPA programs. You will prepare detailed audit reports, track corrective actions, and support regulatory inspections.

Strong writing and cross-functional collaboration are essential. Requirements include a bachelor's degree in a scientific/technical field, 1–2 years of regulated-audit experience, and knowledge of FDA/ICH/GMP standards.

Qualifications

• Minimum one to two years of auditing experience in a regulated biopharma environment.
• Strong knowledge of regulatory requirements (FDA, ICH, EU GMP) and quality systems.
• Ability to produce clear audit reports with evidence and recommendations.

Responsibilities

• Plan, execute, and report on internal audits of GxP processes.
• Lead or support supplier/vendor audits and monitor performance.
• Prepare audit agendas, checklists, and sampling strategies.
• Document findings with classifications, evidence, and recommendations.
• Track CAPAs and drive timely closure.
• Support inspection readiness and liaise during regulatory inspections.
• Perform gap assessments against regulations and propose improvements.
• Collaborate across QA/QC, Manufacturing, Regulatory, and IT.
• Maintain audit schedules, metrics, and dashboards; report status to stakeholders.
• Contribute to policy/SOP development and continuous improvement.

Skills

Auditing experience

FDA 21 CFR Parts 210/211

ICH Q-series & GMP

Risk-based auditing

CAPA effectiveness verification

Root cause analysis

Documentation & reporting

Stakeholder management

Technical writing

Education

Bachelor's degree in a scientific or technical field

Certified Quality Auditor (CQA) - ASQ

Job description

Capricor Therapeutics, Inc. in San Diego seeks an Audit/QA professional to lead internal audits of GxP processes, supplier audits, and CAPA programs. You will prepare detailed audit reports, track corrective actions, and support regulatory inspections.

Strong writing and cross-functional collaboration are essential. Requirements include a bachelor's degree in a scientific/technical field, 1–2 years of regulated-audit experience, and knowledge of FDA/ICH/GMP standards.