Experience

ROCHE MOLECULAR SYSTEMS EMPLOYEE HEALTH CLINIC

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Diagnostic Quality Technician

  • May 2020 - Present



Ortho Clinical Diagnostics

• United States
• Medical Device
• 700 & Above Employee

• Biovue Manufacturing Technician

  • Dec 2016 - Oct 2019



Aprecia Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmaceutical Technician

  • Jan 2016 - Sep 2016

  Responsible for daily activities during all manufacturing and packaging processes with strict adherence to safety, quality, SOP's and GMP's. Operate, set up, monitor, trouble shoot, sanitize and clean all Packaging & Manufacturing Rooms (Dispensing, Blending & Mixing, Print Fluid Processing and Forming). Weighs and measures materials to ensure correct quantities are used. Monitor environmental conditions ( temperature, pressure and humidity) in Manufacturing and Packaging Rooms Performed maintenance, calibrations and changed parts on all equipment during product changeovers. Set up and reviewed batch records while in process and at the end of batches ensuring completeness and error free. Performed in process testing and AQL Sampling, Collected retain, release and other samples for labs. Ensure appropriate actions are taken in the event of deviations and quality issues. Communicate batch/equipment status and issues to peers. Actively participated in daily shift change meetings. Knowledge of using personal protective equipemnt. Trained other employees in all areas of Manufacturing & Packaging. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Packaging Lead

  • Jan 2005 - Dec 2015

  PRC(Peer Review Coordinator). Provided constructive feedback and performed biannual evaluations for team work cells.SME(Subject Matter Expert) for Bottle, Blister and Secondary Packaging Lines. Certified OJT (On the Job Trainer) responsible for new employee development. Trained individuals on equipment, documentation and procedures.Certified Line Clearance Inspector for all packaging lines. Batch Record and SOP Reviewer - Review batch records upon completion for accuracy, create and modify SOP's.Assist internal and external auditors from Compliance, FDA & WHOCollaborate with Technical Writers in creating protocols and Support Staff with CAPA's.Principles of 5S. Lean Manufacturing.Validation of new equipment and new products. Show less

• PQI (Packaging Quality Inspector)

  • Jan 2004 - Jan 2005

  Takes ownership of work cell quality issues and communicates effectively within the team and support staff. Monitors various stages of packaging in-process checks and sampling in accordance to batch record specifications SOP and GMPs.Performed in-process checks via automated systems (MES)Prepare retain and stability samples of controlled/uncontrolled finished goods.Set up AQL forms and Sampling Guides.Bulk product verification and in-process sampling.Certified Line Clearance Inspector for all packaging lines.Assisted in job hazard analysis audits.Monitor and document temperature, pressure and humidity of Isolator Containment Unit.Issued drug product, labels, outserts and components for packaging orders.Prepare documents for batch records. Show less

• Packaging Operations Technician/Material Handler

  • Feb 2000 - Jan 2004

  Operate, disassemble, assemble, clean, monitor and maintain various packaging equipment throughout the Packaging Process in a team-based environment at a high level of efficiency while ensuring quality output. Responsible for the proper movement, handling and accounting of components, bulk product and Finished Goods via electronic systems.

• Warehouse Associate

  • Feb 1999 - Feb 2000

  Performed all aspects of GMP warehousing operations including,receiving, general warehouse and cold storage & controlled drug inventory management, movement of raw materials and finished product throughout all departments.