Jeffrey Strantz Email & Phone Number

• Provided technical services for product development.• Responsible for Product Master Documentation; creating Master Batch Records and new revisions for current products.• Reviewed and revised raw material and finished product specifications and CoA's.• Managed redline KPI (Key Performance Indicators) project.• Supervised and trained team members.

Plantation, Florida

• Perform production support within a cleanroom (class 100) environment while practicing 6S lean process improvements.• Set up and qualify machinery/equipment for production and perform daily preventative maintenance.• Diagnose, troubleshoot, and resolve machine/equipment issues.• Inspect in-process material and identify any non-conforming material not meeting specifications.

Miami, Florida

• Responsible for final documentation review of production batch records, analytical testing data, and vendor component CoA/CoC for accuracy and alignment with cGMP, cGLP, and regulatory compliance requirements.• Assessed raw materials, components, and in-process/finished products for acceptability or rejection and determine release, quarantine, or rejection.• Liaison with QC department to ensure COA's generated were in line with approved specifications.• Supported QA inspectors in the review of AQL sampling plans performed were within specifications.• Served as member of validation team for development of electronic batch records. • Provided customer service by attending to needs, requests, and demands in a timely manner.

Fort Lauderdale, Florida

• Reviewed completed manufacturing and packaging batch records. • Determined release or rejection of in-process materials and finished goods.• Conducted ongoing assessments of Quality Assurance and other department Standard Operations Procedures (SOPs) and made recommendations for revisions and improvements.• Using Microsoft Excel, collected and entered data for trend analysis to create tracking reports for QA metrics. • Revised Packaging Batch Records to improve usability.

Weston, Florida

• Tracked all controlled substance material purchases which were manufactured, transferred, sold, and distributed for ARCOS (Automation of Reports and Consolidated Orders System) reports. • Created and submitted ARCOS reports to the DEA.• Managed movement of controlled substance materials, and completed required documentation. • Performed inventory, updated logs, and prepared reports. • Collected data from Master Batch Records (MBRs) and entered into Track & Trend database.• Performed audits of MBRs, inventory logs, and waste destruction files.

Fort Lauderdale, Florida

• Monitored production quality control to ensure finished product had adequately defined identity, strength, quality, and purity.• Calibrated laboratory equipment (analytical balance, gas chromatograph, multi-channel analyzer, pH meter, dose calibrator, automatic pipettes) per maintenance schedule.• Prepared chemicals and agents for use in production.• Analyzed finished product via QC tests including GC, TLC, pH, and Sterility. • Reviewed batch records and conducted internal audits to measure compliance with cGMPs.• Performed and managed inventory of components used for production.• Performed aseptic techniques while working in a clean room environment.