Kaltrina Berisha
South Plainfield
Summary
Operations and Training professional with experience in GMP-regulated cell therapy logistics, scheduling, and trainee development. Skilled in supporting new hire training, process qualification, SOP-based execution, LMS/compliance training, and operational readiness within clinical and commercial CAR-T environments. Strong background in coaching team members, conducting knowledge checks, identifying training gaps, improving processes, and partnering with Operations leadership to ensure compliant, right-first-time execution.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Cell Therapy Scheduling & Logistics Specialist (NORAM)
Bristol Myers Squibb (BMS)
Summit, NJ
12.2024 - Current
- Coordinate 50+ patient-specific autologous cell therapy cases across manufacturing plants, clinical sites, and global logistics partners in a GMP-regulated CAR-T environment.
- Implemented new and updated training materials for Operations team members, including job aids, process walkthrough, case-based examples, and training presentations to improve trainee understanding, compliance, and process consistency.
- Support daily clinical and commercial operations by managing scheduling workflows, manufacturing slot alignment, product release timelines, and temperature-controlled logistics.
- Train, coach, and support new Operations team members on scheduling workflows, SOP adherence, escalation pathways, documentation standards, and compliance requirements.
- Assist with onboarding and trainee development through side-by-side training, process walkthrough, case-based examples, and hands-on system guidance.
- Conduct informal knowledge checks and provide feedback to help identify gaps in trainee understanding, confidence, and right-first-time execution.
- Partner with Operations leadership, Quality, SAS, Manufacturing, Logistics, and courier teams to resolve process gaps, operational issues, and training opportunities.
- Create, revise, and improve training materials, job aids, process guidance, and PowerPoint content to support consistent execution across Operations.
- Monitor operational trends, case issues, and recurring questions to recommend process improvements and strengthen training effectiveness.
- Maintain COI compliance, ALCOA+ data integrity, Good Documentation Practices, and GMP/FDA regulatory expectations within Salesforce and internal systems.
- Support compliance readiness by reinforcing procedure adherence, documentation accuracy, LMS/compliance course completion, and quality training expectations.
- Contribute to KPI tracking, quality training metrics, and continuous improvement initiatives to reduce escalations and improve operational efficiency.
- Resolve logistics deviations including weather delays, packaging nonconformances, airline refusals, courier changes, and schedule updates with minimal patient impact.
QA Tester & Customer Care Implementer
NOEXIS
New York, NY
04.2022 - 11.2024
- Developed and executed detailed test plans and scenarios within Agile/Scrum environments.
- Identified, documented, and tracked system defects using JIRA and Confluence.
- Conducted root cause analysis to support quality and performance improvements.
- Implemented Zendesk CRM workflows to streamline case tracking and SLA compliance.
- Audited documentation and case records to ensure regulatory and operational accuracy.
Guest Relations Supervisor
Aer Lingus
Jericho, NY
07.2015 - 05.2022
- Managed daily airline passenger service operations and customer relations activities in a fast-paced airport environment.
- Supervised and supported 60 front-line employees, ensuring consistent service delivery and compliance with airline policies and operational procedures.
- Conducted weekly coaching sessions and performance evaluations, reviewing employee calls, customer cases, and service metrics to improve performance and service quality.
- Assisted passengers during travel disruptions, last-minute rebookings, and baggage issues, utilizing Amadeus and WorldTracer systems to resolve cases efficiently.
- Monitored operational workflows and collaborated with airport operations teams to ensure smooth passenger processing and on-time service delivery.
- Supported station leadership with operational reporting, performance monitoring, and issue resolution during daily operations.
- Provided guidance and real-time support to front-line staff during high-volume periods and irregular operations.
Education
Bachelor of Science (B.S.) - Business Administration
Berkeley College
New YorkCompleted Coursework toward Associate in Science (A.S.) - Business Management
High School Diploma -
City-As-School
New York, NYSkills
- Operations Training & Qualification
- GMP / FDA-Regulated Environment
- CAR-T / Cell Therapy Operations
- New Hire Training & Coaching
- Process Qualification Support
- Side-by-Side Training / OJT Support
- Training Assessments & Knowledge Checks
- LMS / Compliance Training
- SOP Review & Procedure Updates
- Training Gap Identification
- Quality Training Metrics
- Right-First-Time Execution
- Continuous Improvement
- Cross-Functional Operations Support
- Clinical & Commercial Manufacturing Support
Certification
- Lean Six Sigma White Belt
- Lean Six Sigma Yellow Belt
- Agile with Atlassian JIRA
- Scrum Framework
- Software Testing & Automation Specialization
Timeline
Cell Therapy Scheduling & Logistics Specialist (NORAM)
Bristol Myers Squibb (BMS)
12.2024 - Current
QA Tester & Customer Care Implementer
NOEXIS
04.2022 - 11.2024
Guest Relations Supervisor
Aer Lingus
07.2015 - 05.2022
Completed Coursework toward Associate in Science (A.S.) - Business Management
High School Diploma -
City-As-School
Bachelor of Science (B.S.) - Business Administration
Berkeley College