Capricor Therapeutics, Inc.

Quality Assurance Associate II/III – Donor Eligibility, Suitability

Capricor Therapeutics, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • United States

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Salary

💰 $75,000 - $95,000 per year

About the role

  • Perform QA review of donor screening documentation for donor-derived starting materials, including donor medical history, behavioral risk assessment, and recovery documentation.
  • Review infectious disease testing results and laboratory reports to ensure compliance with regulatory donor eligibility requirements.
  • Verify completion and accuracy of donor eligibility records including required testing, screening, and documentation.
  • Assess hemodilution evaluations, where applicable, to ensure validity and reliability of donor infectious disease testing results.
  • Ensure donor records meet applicable regulatory requirements under 21 CFR 1271 Subpart C and internal procedures.
  • Document donor suitability determinations and ensure proper QA approval prior to use of donor-derived materials in manufacturing.
  • Ensure donor eligibility determinations are completed prior to acceptance and use of donor-derived starting materials for manufacturing.
  • Ensure donor eligibility records are complete, traceable, and maintained in accordance with regulatory and internal record retention requirements.
  • Ensure donor screening and eligibility review documentation is handled in accordance with HIPAA privacy requirements and company procedures governing the protection of protected health information (PHI).
  • Perform QA review of GMP manufacturing batch records for completeness, accuracy, and compliance prior to product disposition.
  • Support QA oversight of manufacturing operations, including review of manufacturing documentation and logbooks.
  • Review deviations, investigations, and CAPAs for adequacy, root cause determination, and regulatory compliance.
  • Participate in change control assessments to evaluate potential quality and regulatory impact.
  • Support review and approval of SOPs, protocols, reports, and controlled quality documents.
  • Ensure compliance with ALCOA+ data integrity principles across GMP documentation.
  • Support internal audits, regulatory inspections, and quality system audits.
  • Ensure documentation practices meet GMP and regulatory expectations.
  • Identify compliance risks and escalate quality concerns as appropriate.
  • Assist in implementation of quality improvements and corrective actions.
  • Partner with Manufacturing, Quality Control, Clinical Operations, and Regulatory Affairs to ensure donor eligibility and manufacturing processes are compliant and well controlled.
  • Provide QA guidance on donor eligibility requirements and applicable regulatory expectations.
  • Participate in cross-functional meetings related to donor material qualification and use.
  • Perform rapid yet thorough review of donor information and make eligibility determinations in a timely manner, typically within approximately 20 minutes of receipt of complete donor screening and testing information, to support time-critical acceptance decisions.
  • Determine donor suitability based on review of screening documentation and regulatory requirements.
  • This position performs and documents donor eligibility and suitability determinations, independently or in coordination with another qualified QA reviewer, that directly affect the qualification and release of donor-derived starting materials for manufacturing.
  • Escalate complex or unclear donor eligibility determinations to QA management or the Medical Director as required.
  • Apply sound, risk-based judgment in situations where donor information may be incomplete, unclear, or require interpretation.

Requirements

  • Bachelor’s degree in life sciences, biology, biotechnology, health sciences, or a related discipline preferred.
  • Or equivalent combinations of education, training, and directly applicable experience demonstrating the ability to perform regulated documentation review and donor eligibility determinations will be considered.
  • Typically requires 4–8 years of experience in a regulated environment supporting Quality Assurance, donor eligibility review, tissue banking, transplant services, biologics manufacturing, or cell therapy operations.
  • Experience performing donor screening or donor suitability determinations is strongly preferred. Relevant experience may include review of donor medical history questionnaires, behavioral risk assessments, and infectious disease testing records in support of donor eligibility decisions.
  • Experience in blood, plasma, or platelet donor suitability programs (e.g., blood centers or transfusion services), including evaluation of donor screening documentation and application of donor eligibility criteria, is considered highly relevant.
  • Candidates with experience in tissue banking, transplant programs, HCT/P operations, or biologics/cell therapy manufacturing environments are also strongly encouraged to apply.
  • Knowledge of 21 CFR 1271 donor eligibility requirements.
  • Familiarity with GMP regulations (21 CFR Parts 210, 211, and applicable biologics regulations within the 600 series).
  • Understanding of donor screening, infectious disease testing, and donor record review.
  • Knowledge of GTP/GMP documentation practices and data integrity principles.
  • Knowledge of HIPAA privacy requirements and appropriate handling of protected health information (PHI) associated with donor medical records and eligibility documentation.
  • Strong attention to detail and documentation review skills.
  • Ability to interpret regulatory requirements and apply them to operational processes.
  • Ability to support time-sensitive donor eligibility activities, including availability outside of standard business hours or on short notice to meet operational needs.
  • Effective cross-functional communication skills.
  • Strong organizational and problem-solving abilities.
  • Ability to work independently while maintaining compliance standards
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
QA reviewdonor screeningdonor eligibility determinationsGMP regulationsregulatory compliancedata integrity principlesdocumentation practicesinfectious disease testingtissue bankingbiologics manufacturing
Soft Skills
attention to detailorganizational abilitiesproblem-solvingeffective communicationindependent workrisk-based judgmenttime managementcross-functional collaboration