Quality Compliance Associate I/II
Posted 29 days ago
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Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain).
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Lead or support supplier/vendor audits and monitor ongoing supplier performance.
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Prepare detailed audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities.
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Document findings clearly; issue audit reports with classifications, evidence, and actionable recommendations.
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Track and verify effectiveness of CAPAs (Corrective and Preventive Actions) and drive timely closure.
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Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA).
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Perform gap assessments against current regulations and industry standards; propose reasonable improvements.
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Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems.
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Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders and management.
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Contribute to policy/SOP development, training, and continuous improvement initiatives.
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Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
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1-2 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry.
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Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles.
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Experience performing audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control).
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Strong technical writing skills and attention to detail; able to produce clear, evidence-based audit reports.
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Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification.
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Excellent communication and stakeholder management skills; comfortable engaging at all levels.
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Certified Quality Auditor (CQA) – ASQ, or equivalent certification.
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Experience auditing CMOs/CDMOs and complex supply chains.
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Background with data integrity, CSV, Annex 11, and Part 11 assessments.
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Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing.
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Knowledge of ISO 9001/13485, 21 CFR 210/211, and pharmacovigilance quality systems (as applicable).
Other open roles at Capricor Therapeutics(6)
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, Deramiocel, an allogeneic cardiac-derived cell therapy that is currently in late-stage development for the treatment of Duchenne muscular dystrophy (DMD). Capricor is also developing its exosome technology as a next-generation therapeutic platform. Capricor’s current focus is on developing exosomes capable of delivering nucleic acids as well as proteins to treat or prevent a variety of diseases.
Key team members
Jason Weid
Kevin Berth
Rob Carey
Paul Voss
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