JASON A. COHEN
Tampa
Summary
A proactive and results-oriented professional skilled with combined experience in manufacturing management and quality assurance. Proficient in lean methodology and implementing continuous quality/process improvements. Proven track record in managing multiple projects while building cohesive teams focusing on production goals, quality, compliance, and throughput.
Overview
2026
2026
years of professional experience
Work History
QA Manager, Quality Metrics
ADMA BIOLOGICS
Boca Raton, FL
01.2020 - 01.2026
- Tracked and analyzed plant-wide compliance metrics and reported to senior management monthly. Reported results on established key performance indicators (KPIs) related to quality and led initiatives to strengthen quality systems by addressing potential compliance gaps and emerging trends. In addition, headed the Executive Quality System Review Board (QSRB) meetings (Quarterly). Initiatives enhanced compliance with industry regulations and standards.
- Collaborated with cross-functional teams to identify and resolve quality issues, fostering a culture of continuous improvement. Actions prevented future recurrence of similar problems,
- Leap award winner (2023) for excellence in leadership, entrepreneurship, accountability, and performance.
- An integral part of the cross-functional team for internal and external quality audits. Ensured that ADMA quality standards were aligned with the existing regulations.
- Managed/Optimized CAPA quality system.
- Provided support to ongoing manufacturing projects related to yield enhancement. The optimized yield was achieved, with ~20% from the same starting plasma volume.
Consultant
TROPICAL LABS
Tampa, FL
01.2020 - 01.2020
- Advise client regarding cGMP, cGLP, and GDC compliance.
- Built the Quality Assurance group, including a QA Manager, 2 QA Technicians (MQA), and a Document Control Specialist
- Designed new processes for supply chain (material management), chain of custody, Label control, Batch Records for manufacturing, along with packaging, process flow, and floor/process audits.
Technical Operations and Contract Manufacturing Lead
ROMARK LABORATORIES
Tampa, FL
01.2017 - 01.2019
- Spearheaded cGMP Commercial Manufacturing at contract manufacturing organizations (CMO) to meet the required deadlines.
- Cross-functional collaboration with Regulatory, Compliance, and Quality departments; vendor and service-provider liaison, for commercial drug product manufacturing
- Streamlined production planning and systems between sites (CMO and Romark)
- Met the site qualification deadline in our receiving plant in Puerto Rico.
- Provided ongoing support through technology transfer and identified improvement opportunities at the receiving site in Puerto Rico.
- Steered deviations, investigations, and CAPAs. Collaborated with Quality in identifying improvement opportunities through root cause analysis
Operations Supervisor
CATALENT, PHARMA SOLUTIONS
St. Petersburg, FL
01.2015 - 01.2017
- Management and control of all GMP commercial manufacturing. Assured that all projects are executed in a compliant and efficient manner.
- Planned and executed the production schedule, including human and material resources, to ensure the product is delivered on time and under budget while maintaining quality standards.
- Chaired kaizen events to define and improve gowning process flow and cleaning validation projects
- Designed training programs for new employees through Compliance Wire and ongoing projects to improve the effectiveness of existing staff
- Responsible for writing product/process discrepancies and investigations via Trackwise
- Maintained a high-quality environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures through periodic inspections.
- Responsible for managing product/process discrepancies and investigations
- Investigated customer/consumer product complaints.
- Participated in cross-functional audits.
Manager, Clinical Manufacturing
XCELIENCE, LLC
Tampa, FL
01.2007 - 01.2015
- Worked with cross-functional teams to improve overall efficiency. Plant efficiency increased by 36%.
- Provided administration and control of all GMP clinical manufacturing operations and ensured that all projects were designed and executed in a compliant and efficient manner.
- Built and modified the Manufacturing Department infrastructure to include a second shift with new leadership positions. Developed and established a Master planner, GMP Purchasing/Logistics Coordinator, 3 Supervisors, and 5 additional operators.
- Worked with business development and project management personnel to evaluate new projects for proposals (RFP) to determine project scopes, statements of work, task durations, layouts of equipment & rooms, and project budgets (Visual Management)
- Streamlined production schedule based on business demand analysis (through Visual Management).
- Provided continuous alignment with Product Development and Project Management’s scope with strategic capacity planning to modify the schedules to enhance effectiveness towards the completeness of multiple projects.
- Part of the cross-functional quality audit team.
- Created and implemented training curricula for the manufacturing personnel
- Led regular stand-up meetings, events, and improvement projects with measurable goals.
- Created Master Batch Records and Equipment Qualification Protocols
- Sourced and procured processing equipment and materials for manufacturing
Manufacturing Supervisor
King Pharmaceuticals
St. Petersburg, FL
2004 - 2007
- Supervised daily manufacturing operations to ensure compliance with safety and quality standards.
- Coordinated production schedules to optimize workflow and reduce bottlenecks.
- Trained and mentored new staff on equipment operation and safety protocols.
- Implemented process improvements that enhanced operational efficiency and reduced waste. Chaired various continuous improvement projects (Lean Six Sigma (Kaizen, Kanban)) with savings of ~$175,000 (Waste Reduction and Documentation Flow Improvement). · Spearheaded an increase in productivity (by 30%) by optimizing resources and people. Awarded the Commitment to Excellence Award.
- Collaborated with cross-functional teams to achieve production goals and optimize workflow.
Education
Bachelor of Arts - Chemistry
University of South Florida
Tampa, FloridaSkills
- Languages: Spanish (Fluent), English (Native)
- CMO and CDMO Experience
- Quality metrics monitoring
- Quality Systems Management
- CAPA Program Leadership, Quality Audits (cGMP), Root Cause Analysis, Risk Management, HACCP, and Quality by Design
- Master Control, Compliance Wire, Track-Wise, Documentum, Soft-Expert
- Scrum Fundamentals Certificate & Lean Six Sigma Green Belt
- Cross-functional Collaboration, Team Building
- ERP/MRP - SAP (46), AS400, JDE and POMs web
Timeline
QA Manager, Quality Metrics
ADMA BIOLOGICS
01.2020 - 01.2026
Consultant
TROPICAL LABS
01.2020 - 01.2020
Technical Operations and Contract Manufacturing Lead
ROMARK LABORATORIES
01.2017 - 01.2019
Operations Supervisor
CATALENT, PHARMA SOLUTIONS
01.2015 - 01.2017
Manager, Clinical Manufacturing
XCELIENCE, LLC
01.2007 - 01.2015
Manufacturing Supervisor
King Pharmaceuticals
2004 - 2007
Bachelor of Arts - Chemistry
University of South Florida