Quality Assurance Associate II/III – Donor Eligibility & Suitability

Capricor Therapeutics•San Diego, CA

1d•$75,000 - $95,000

About The Position

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The QA II/III is responsible for performing Quality Assurance oversight and review activities supporting donor eligibility determinations and GMP manufacturing operations for cell therapy products. This role ensures that donor-derived starting materials used for cell therapy manufacturing meet regulatory and internal quality requirements prior to use. The position supports compliance with applicable regulations including 21 CFR 1271, 21 CFR Parts 210/211, and applicable GTP/GMP guidance. QA II/III performs independent review of donor screening documentation, infectious disease testing results, and associated records to ensure donor suitability prior to release of starting materials for manufacturing. Donor eligibility determinations represent a critical quality decision affecting the suitability of donor-derived starting materials for use in cell therapy manufacturing. This role has the authority to perform QA review and approval of donor eligibility and suitability determinations in accordance with approved procedures and regulatory requirements. In addition, the role supports routine QA Operations activities including batch record review, deviation oversight, change control support, and inspection readiness. The level of this position (QA II or QA III) will be determined based on the candidate’s experience, depth of knowledge, and demonstrated ability to independently perform donor eligibility and suitability determinations with appropriate judgment and minimal oversight.

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

Nice To Haves

Experience with cell therapy or advanced therapy medicinal products (ATMPs).
Familiarity with transplant or tissue banking standards (e.g., AATB, OPTN/UNOS).
Hands-on experience performing donor suitability determinations in blood banking or plasma collection environments, including application of donor deferral criteria, review of donor medical history, and interpretation of infectious disease testing results in accordance with applicable regulatory and industry standards (e.g., 21 CFR 1271, 21 CFR 630, AABB, PPTA).
Experience working within electronic quality management systems (eQMS).
Prior experience supporting regulatory inspections.

Responsibilities

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.