Quality Assurance Associate II/III – Donor Eligibility & Suitability

Responsibilities
Donor Eligibility & Suitability Review
- 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 per regulatory and internal record retention requirements
- Ensure donor screening and eligibility review documentation is handled in accordance with HIPAA privacy requirements

QA Operations Support
- 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

Compliance & Inspection Readiness
- 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

Cross-Functional Collaboration
- 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

Decision-Making Responsibilities
- Perform rapid yet thorough review of donor information and make eligibility determinations in a timely manner (typically within ~20 minutes of receipt of complete screening/testing information)
- Determine donor suitability based on review of screening documentation and regulatory requirements
- Perform and document donor eligibility and suitability determinations that affect qualification and release of donor-derived starting materials
- Escalate complex or unclear donor eligibility determinations to QA management or the Medical Director as required
- Apply sound, risk-based judgment when donor information is incomplete, unclear, or requires interpretation

Requirements
- Bachelor’s degree in life sciences, biology, biotechnology, health sciences, or a related discipline preferred
- Or equivalent education/training/experience demonstrating ability to perform regulated documentation review and donor eligibility determinations
- Typically 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 strongly preferred (e.g., donor medical history questionnaires, behavioral risk assessments, infectious disease testing records)
- Experience in blood/plasma/plate donor suitability programs (e.g., blood centers/transfusion services) considered highly relevant
- Experience in tissue banking, transplant programs, HCT/P operations, or biologics/cell therapy manufacturing environments strongly encouraged
- 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 handling of PHI
- 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 standard business hours on short notice
- Effective cross-functional communication; strong organizational and problem-solving abilities; ability to work independently while maintaining compliance

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

Application Instructions
- Candidates will only be contacted by an official Capricor email address (@capricor.com).