Matthew Yozzo

Performed calibration on instruments to maintain precise pressure, flow, temperature, CO2, and RH readings, timers, balances, level, conductivity, and pH devices onsite

· Entering data into Computerized Maintenance Management Systems (CMMS) such as Blue Mountain Regulatory Asset Manager (RAM)

· Working knowledge of Building Management System (BMS, Building Automated Systems (BAS)

· Troubleshooting instruments

· Versed in selecting appropriate calibration standards and calculating test

accuracy ratios

· Calibrating HVAC, Solid Dose manufacturing process equipment, Cell Culture Bio

Manufacturing process equipment, support equipment calibrations (purified water

systems, water for injection systems, clean steam generators, WFI stills, CIP skids,

Point of Use coolers, autoclaves and glass washers)

· Calibrating Analytical instrumentation, HPLC, Dissolution baths, Viscometers and

syringe pumps.

· Training annually on Good Documentation Practices (GDP) and current Good

Manufacturing Practices (cGMP) training

• Carry out the testing/ analysis of raw materials, packaging components, intermediate batches, packaging and finished products in a timely manner, as required
• Support routine raw material, packaging material, bulk and finished product disposition decisions in a timely manner
• Follow all applicable reduced testing programs as well as annual full testing using USP/NF, FCC, JSCI Pharmacopoeia and company methodology
• Check all relevant documentation as part of the analysis of raw materials (e.g
• CoA, tank cleaning certificate, hose cleaning certificate, etc) and communicate with the responsible person in case of missing / insufficient documentation
• Data entry of test results in laboratory notebooks and in internal data systems (SLIMS, SAP, etc)
• Ensure that all events with a potential impact on Product Quality (+ Safety, Efficacy, Stability), Quality Compliance, EHS and Laboratory Cycle Time are immediately escalated to the responsible senior personnel / management (OOS, OOT, HiPo, DI, equipment breakdown, etc)
• Support the immediate trouble shooting and investigation of out of specification results
• Support method and/or product transfer and NPI activities and execution of test method validation protocols
• Preparation and documentation of test solutions and standards and their proper storage
• Clean, maintain, calibrate and support the validation of laboratory equipment
• Order chemicals and consumables from the appropriate supplier
• Perform tasks according to the instructions of the reporting manager which are in scope of role.

• Comply with all current IOPS cGxP’s (e.g
• Good Manufacturing Processes, Good Documentation Practices etc.)
• Complete all required training items (SOP’s, CBT’s, OJT’s ILC’s etc.) within the associated time frames prior to performing any associated tasks
• Performs all tasks required for work completion per approved standard operating procedures (SOPs)
• Comply with all IOP’s Environmental, Health & Safety policies / procedures associated with the tasks to be performed
• Comply with all Local, State and Federal regulatory requirements associated with all tasks performed
• Trained newly hired employees by explaining company procedures, job duties and performance expectations.
• Adhered to safety protocols to minimize equipment damage and avoid injuries.
• Conducted tests on product samples and recorded results.
• Maintained lab cleanliness and safety standards.
• Calibrated, validated or maintained laboratory equipment.
• Interpreted test results, compared to specifications and control limits and recommended data for release.

• Perform sampling and testing of soils, concrete and asphalt on construction sites
• Drive company vehicles to and from job sites in a safe and responsible manner
• Perform stripping, weighing and logging of concrete cylinders that have already been cast.

• Perform laboratory/quality functions by testing, collecting data, and analyzing findings on raw materials and finished goods
• Comply with FDA, USDA, and GMP policies
• Perform all tasks in a safe manner to ensure achievement of Quality, Service, and Cost objectives
• Comply with all standard operating procedures and requirements under the Quality System
• Perform microbiological analysis on finished product, incoming ingredients and environmental swabbing
• Analyze incoming ingredients, blends, and finished product to meet specifications