Carla Cooper

Professional with 15+ years of experience managing regulatory compliance, process optimization, and strategic leadership across healthcare, blood/plasma collection, and call center environments. Led program operations, implemented corrective action plans, and drove continuous improvement initiatives in compliance with FDA, AABB, OSHA, and HIPAA regulations. Transformed underperforming programs, enhanced operational workflows, mitigated risks, and maintained quality assurance to achieve sustainable organizational growth.

Leukopaks Operations Manager at Grifols Bio Supplies (2022-05 – 2024-09)

Oversaw regulatory adherence for RUO Leukopak collections for human subjects research, clinical trials, cell therapies, and GMP standards in alignment with FDA guidelines. Directed day-to-day program operations, workflows, and staff assignments to enhance regulatory compliance.

• Coordinated training initiatives, equipping personnel with the expertise required for regulatory-compliant Leukopak processing and storage.
• Fulfilled regulatory and operational requirements within the Leukopaks program by expertly negotiating and managing contractual agreements.

Leukopaks Program Manager - Direct Patient Care/Emerging Cell/Gene Therapy at American Red Cross (2019-09 – 2021-12)

Investigated non-conformances and customer concerns and implemented corrective actions to enhance operational standards. Administered and provided training for new electronic platforms, including Wellsky Biotherapies and Resource Manager Scheduling. Led staff management initiatives, including hiring, training, and performance evaluation. Oversaw program operations and assigned training and duties to staff to maintain smooth workflows.

• Enforced regulatory adherence and operational efficiency by implementing CAPAs and Effectiveness Checks (EC).
• Supported IRB review for new and existing clinical research and cell therapy customers as IRB liaison and primary contact for yearly Continuation Applications.
• Strengthened regulatory compliance by reviewing and submitting Amendment Applications addressing staff procedures, donor safety, medical records, and clinical batch release.
• Facilitated collaboration across departments, functions, and geographies by streamlining communication for Leukopaks program activities and clinical research customers.
• Ensured confidentiality and data integrity by scheduling donor prescreens and collection appointments.
• Increased donor retention and program sustainability by developing procedures for donor recruitment/engagement.

Ops Supervisor - Donor Services Disaster/Fundraising (HQs) at American Red Cross (2012-09 – 2019-09)

Led call center workflow by assigning tasks, training staff, scheduling shifts, and analyzing performance metrics. Recruited top talent, evaluated performance, and coached employees to foster a productive work environment. Collaborated with internal departments and conducted in-depth research to address donor requests.

• Developed and implemented process enhancements that consistently led to exceeding key performance indicators (KPIs) across multiple operational areas.
• Improved donor satisfaction and engagement by investigating donor concerns via follow-up outreach and research.
• Refined query resolution and service quality by mentoring staff and providing technical and administrative support.
• Mediated sensitive customer complaints involving fraud, refunds, and reimbursement disputes.
• Leveraged Salesforce CRM expertise to troubleshoot complex client issues as a 2nd-tier contact.

Operations Supervisor - DCSC Donor Client Support Center at American Red Cross (2009-10 – 2012-09)

Directed a diverse team of Donor Qualification Specialists, Client Support Specialists, RNs, LPNs, Donor Counselors, Case Investigators, and Team Support Specialists within a call center environment. Worked with team supervisors and the quality assurance department to conduct audits, deliver training, and provide strategic guidance. Investigated deviations and incidents of non-conformance and implemented corrective measures.

• Aligned team objectives with company goals by refining KPI measurement strategies to ensure sustained operational success and continuous improvement.
• Strengthened workforce performance by directing HR operations, including recruiting, assessing staff, and coaching employees for professional growth and conflict resolution.
• Secured successful inspection response submissions by conducting internal audits, performing risk assessments, and supporting external FDA audits.
• Developed and executed CAPAs, SCAs, and Effectiveness Checks (EC) to drive continuous improvement.

Senior Associate Problem Manager/Quality Associate at American Red Cross

Blood Collection Team Supervisor at American Red Cross

Associate Problem Manager/Quality Associate at American Red Cross

Bachelor of Science (BS) in Health Administration & Management – University of Phoenix (2012)

Diploma in Medical Assisting – Remington College