Quality Compliance Associate I/II
Capricor Therapeutics, Inc.
June 25, 2026
Remote friendly (San Diego, CA)
United States
$70,000 - $82,000 USD yearly
Operations
Key Responsibilities:
- Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain).
- Lead or support supplier/vendor audits and monitor supplier performance.
- Prepare audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities.
- Document findings clearly; issue audit reports with classifications, evidence, and recommendations.
- Track and verify CAPA effectiveness and drive timely closure.
- Support inspection readiness and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA).
- Perform gap assessments against regulations/industry standards and propose improvements.
- Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems.
- Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders.
- Contribute to policy/SOP development, training, and continuous improvement.
Minimum Qualifications:
- Bachelor’s degree in a scientific/technical field (or equivalent experience).
- 1–2 years of auditing experience in biopharma/biotech/medical devices or related regulated industry.
- Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP.
- Experience auditing quality system elements (Deviation, CAPA, Change Control, Training, Document Control).
- Strong technical writing skills; detail-oriented evidence-based reporting.
- Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification.
- Excellent communication and stakeholder management.
Preferred Qualifications:
- Certified Quality Auditor (CQA) – ASQ (or equivalent).
- Experience auditing CMOs/CDMOs and complex supply chains.
- Background with data integrity, CSV, Annex 11, Part 11 assessments.
- Exposure to biologics, cell & gene therapy, aseptic/sterile manufacturing.
- Knowledge of ISO 9001/13485, 21 CFR 210/211, and pharmacovigilance quality systems (as applicable).
Benefits:
- Employer-sponsored medical, dental, vision; company-paid basic life and AD&D; 401(k) with match; paid time off and company holidays; paid parental leave; additional voluntary benefits/wellness programs (as available).
- Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain).
- Lead or support supplier/vendor audits and monitor supplier performance.
- Prepare audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities.
- Document findings clearly; issue audit reports with classifications, evidence, and recommendations.
- Track and verify CAPA effectiveness and drive timely closure.
- Support inspection readiness and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA).
- Perform gap assessments against regulations/industry standards and propose improvements.
- Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems.
- Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders.
- Contribute to policy/SOP development, training, and continuous improvement.
Minimum Qualifications:
- Bachelor’s degree in a scientific/technical field (or equivalent experience).
- 1–2 years of auditing experience in biopharma/biotech/medical devices or related regulated industry.
- Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP.
- Experience auditing quality system elements (Deviation, CAPA, Change Control, Training, Document Control).
- Strong technical writing skills; detail-oriented evidence-based reporting.
- Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification.
- Excellent communication and stakeholder management.
Preferred Qualifications:
- Certified Quality Auditor (CQA) – ASQ (or equivalent).
- Experience auditing CMOs/CDMOs and complex supply chains.
- Background with data integrity, CSV, Annex 11, Part 11 assessments.
- Exposure to biologics, cell & gene therapy, aseptic/sterile manufacturing.
- Knowledge of ISO 9001/13485, 21 CFR 210/211, and pharmacovigilance quality systems (as applicable).
Benefits:
- Employer-sponsored medical, dental, vision; company-paid basic life and AD&D; 401(k) with match; paid time off and company holidays; paid parental leave; additional voluntary benefits/wellness programs (as available).