Jason A. Cohen
Tampa,Florida
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 along building cohesive teams focusing on production goals, quality, and throughput.
Overview
35
35
years of professional experience
Work History
Manager, Quality Metrics and Reporting
ADMA Biologics
Boca Raton, FL
01.2020 - 01.2026
- Ensured Quality Systems Compliance by leading and supporting activities for departmental process improvements. Analyzed quality performance metrics to identify process trends and areas for improvement.
- Managed/owned CAPA quality system.
- Led cross-functional teams to conduct risk analysis, identify root causes for process/system failures, analyze changes, and establish corrective/preventative actions.
- Directed Quality Review Board (QRB) meeting activities, 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.
- Participated in the cross-functional team for quality audits.
- Steered Executive Quality System Review Board (QSRB) meetings. Developed and reported site-wide metrics, tracked action item status, and evaluated action items for potential trends and compliance gaps.
- Managed Annual Product Reviews
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 - 01.2020
- Spearheaded cGMP Commercial Manufacturing at contract manufacturing organizations (CMO).
- 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)
- 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 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 effectiveness of existing staff
- Responsible for writing product/process discrepancies and investigations via Track wise
- Monitor process controls all applicable areas of the manufacturing operation.
Manufacturing Quality Assurance
Xcelience, LLC
Tampa, FL
01.2007 - 01.2015
- 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 the cross-functional audit program.
Manufacturing Supervisor
King Pharmaceuticals
St. Petersburg, FL
01.2002 - 01.2007
- Strategic planning, leading and organizing of the operational activities.
- Spearheaded an increase in productivity (by 30%) by optimizing resources and people. Awarded Commitment to Excellence Award.
- Created a culture of lean manufacturing and continuous improvement through operational leadership.
- Chaired in various continuous improvement projects (Kaizen Blitz)-Waste Reduction in packaging and Documentation (batch records) Flow Improvement
Manufacturing Manager
SRI/Surgical Express
Tampa, FL
01.1996 - 01.2002
- Provided on-time production, labor utilization optimization, and acceptable quality of final product, safety, cGMP compliance, and shipping /receiving.
- Worked with cross functional team on hospital account set-up, customer tours, and other sales/marketing activities.
- Drove operating improvement programs through lean manufacturing methods and through the implementation of empowered work teams which increased plant output.
Chemist
Bausch & Lomb
Tampa, FL
01.1991 - 01.1996
- Performed testing of raw materials, finished products and stability.
- Experienced in high performance liquid chromatography (Bechman & Waters), gas chromatography (HP), and U.V.
Education
B. A - Chemistry
University of South Florida
Tampa, FloridaSkills
- Lean Six Sigma Green Belt
- Staff Development, Team Building
- Vendor Relations
- Bilingual Spanish/English
- Management of projects
- Scrum Fundamentals Certificate
- Quality Audits (cGMP)
- Safety Performance
- Quality Systems Management
- Risk Management
- Root Cause Analysis
- Operational Management, Strategic Planning
- CAPA Program Leadership
- Master Control, Compliance Wire, Track-Wise, Documentum, and Soft-Expert
Languages
Spanish
Native or Bilingual
Timeline
Manager, Quality Metrics and Reporting
ADMA Biologics
01.2020 - 01.2026
Consultant
Tropical Labs
01.2020 - 01.2020
Technical Operations and Contract Manufacturing Lead
Romark Laboratories
01.2017 - 01.2020
Operations Supervisor
Catalent, Pharma Solutions
01.2015 - 01.2017
Manufacturing Quality Assurance
Xcelience, LLC
01.2007 - 01.2015
Manufacturing Supervisor
King Pharmaceuticals
01.2002 - 01.2007
Manufacturing Manager
SRI/Surgical Express
01.1996 - 01.2002
Chemist
Bausch & Lomb
01.1991 - 01.1996
B. A - Chemistry
University of South Florida