Samantha Brooks
Biogen
Mebane,NC
14
years of professional experience
Technical training professional with solid experience in developing and delivering comprehensive training programs. Expertise in instructional design, curriculum development, and technical documentation. Strong focus on team collaboration and flexibility with changing needs, ensuring reliable support and successful project outcomes. Proven ability to enhance team performance and drive impactful results through effective training methodologies.
Work History
Technical Training Specialist III
1 Year 6 Months- Managed training programs by tracking completion rates and verifying compliance with training requirements.
- Administered training curriculum for designated functional areas, ensuring accurate training assignments and tracking progress to enhance workforce readiness.
- Facilitated On-the-Job Training (OJT) program through delivery formats including 1:1, small group, classroom, and virtual settings to support skill development.
- Collaborate with Subject Matter Experts (SMEs) and stakeholders to validate learning objectives and technical accuracy, incorporating feedback.
- Support quality-related training activities, including investigations, corrective and preventive actions (CAPAs), root cause analysis, and audits.
Quality Control Training Specialist
9 Months- Collaborated with management to develop and redesign QC and GMP training curricula tailored to meet specific needs of Quality department.
- Reviewed Standard Operating Procedures (SOPs) to identify training requirements, ensuring alignment with quality and compliance standards.
- Facilitated 2-week LabWorks training course for QC colleagues and contingent workers, monitoring delivery of yearly training and requalifications.
Aseptic Training Specialist Consultant
1 Year 3 Months- Developed and executed training plans and curricula for all employees, ensuring certifications in Aseptic, Isolator, Visual Inspection, Sanitation, and EM Analyst programs.
- Facilitated bi-weekly Global Aseptic and Terminal Sterilization Manufacturing classes for onboarding new employees, delivering foundational knowledge critical for compliance and operational success.
- Planned and supported Aseptic Media Fills on the Training Line, maintaining compliance with current Good Manufacturing Practices and emerging regulatory standards.
- Conducted one-on-one coaching sessions and collaborated with departments to enhance training programs and streamline processes for Learning Management System and MODA platform utilization.
Production Associate III
1 Year 2 Months- Executed aseptic procedures for production of cell therapy products, including CAR-CIK and RNA technology, ensuring compliance with cGMP, GXP, and GDP documentation standards to maintain product integrity.
- Led investigations and initiated deviations with Quality Assurance, managing batch records to uphold quality standards and support regulatory compliance.
- Analyzed quality assurance data to identify trends and recommend process improvements, optimizing supply chain processes and enhancing compliance with industry standards.
Senior Clinical Manufacturing Associate
6 Months- Manufactured blood-derived components following cGMP standards, facilitating process development and technical transfers in cell culture.
- Operated and maintained production equipment, ensuring protocol adherence and completing documentation for process transfer and validation.
- Collaborated with Quality Assurance to review batch and exception reports for GMP lots, supporting continuous improvement in manufacturing operations.
Clinical Manufacturing Associate II
1 Year 7 Months- Employed aseptic techniques in over 15 cleanrooms, adhering to SOPs, GLP, GDP, GXP, GTP, and cGMP standards, while proficiently performing cryopreservation using DMSO base solutions and controlled rate freezers.
- Trained new employees in process development and procedures, managed cell and tissue culture, reagent preparation, and sample shipping, and supported product-related deviation investigations and audit reports to ensure compliance with regulatory standards.
- Represented Primary Process Unit in inter-departmental meetings, contributed to development of clinical trial studies, and evaluated candidates during career fairs to strengthen recruitment efforts.
Lead Pharmacokinetics Technician
3 Years 3 Months- Assisted in the planning, implementation, interpretation, and reporting of Phase 1-4 pharmacokinetic and pharmacokinetic/pharmacodynamic studies, ensuring compliance with FDA regulations and maintaining critical research timelines.
- Managed deviation investigations, change controls, safety inspections, and corrective and preventive actions (CAPAs) to uphold integrity and safety of clinical research processes.
- Collaborated with oncology physicians, clinical research teams, and providers to perform medical coding with MedDRA and WHO-Drug dictionaries and compose case narratives that enhanced clinical trial documentation.
Patient Care Technician- Hematology ONC
3 Years 3 Months- Delivered comprehensive care and promptly resolved patient-related incidents to enhance comfort and satisfaction of patients and families.
- Assisted physicians with bone marrow aspirations and biopsies, monitored vital signs, conducted EKGs, and performed venipuncture while upholding patient confidentiality per HIPAA and hospital regulations.
- Monitored vital signs and reported patient condition changes to nursing staff.
Education
B.S. - HealthCare Management
Master of Science - Adult Learning
Skills
Materials Organization
Quality Compliance
Training Needs Analysis
Online-Based Education
Quality Management Systems
Project Development Management
Regulatory Compliance
Process Improvement
Data Analysis
Learning management systems
Visual Inspection
Technical Training Delivery
Quality Assurance Training
Training Program Design
Project Management
Team Collaboration
LMS skills
Instructional Design
Effective Communication
Training Program Management
Adaptability
Virtual training
E-learning development
Content development
Training delivery
Program management
Timeline
Technical Training Specialist III
Biogen
04.2025 - CurrentRead More
Quality Control Training Specialist
Insight Global, Sanford NC (Pfizer)
07.2024 - 04.2025Read More
Aseptic Training Specialist Consultant
EMMA International Consulting, Rocky Mount NC (Pfizer)
04.2023 - 07.2024Read More
Production Associate III
cōIMMUNE, Inc.
02.2022 - 04.2023Read More
Senior Clinical Manufacturing Associate
Bristol Myers Squibb
06.2020 - 12.2020Read More
Clinical Manufacturing Associate II
Hitachi Chemical Advanced Therapeutics Solutions, LLC (now Minaris Regenerative Medicine)
11.2018 - 06.2020Read More
Lead Pharmacokinetics Technician
Memorial Sloan Kettering Cancer Center
08.2015 - 11.2018Read More
Patient Care Technician- Hematology ONC
05.2012 - 08.2015Read More
University of Phoenix
B.S. from HealthCare Management
Read More
American College of Education
Master of Science from Adult Learning
Read More