Experience

ULTRA TAB LABORATORIES INC.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Quality Assurance Inspector

  • Aug 2013 - Present

  • Ensure all assigned lots are prepared for release immediately upon completion of all FDA requirements; including yield calculations, investigation of any out of specification results, and label reconciliations.• Review and verification of batch records for accuracy, completeness and acceptability as cGMP compliant documents.• Perform in-process and finished product physical-aspect testing and sampling of tablets, ointments, creams, etc. as instructed by batch records and protocols; including weight, hardness and thickness verifications, water content determination with Karl Fischer titration, pH testing and viscosity measurements.• Assist Operations, Production and QC personnel with the execution of process and cleaning validations; ensuring compliance with protocol requirements and cGMPs.• Maintain historical files for controlled documents, including organization and formal archiving in document control.• Issue complete, accurate, traceable Production Batch Records with all affiliated forms and proper logging for traceability.• Daily Caliper & Scale Calibration Verification, monitoring of Chart Recorders; including contractor coordination of various annual and semi-annual calibration programs.• Continuous review of Maintenance Use and Cleaning Logs, Production Logs, and controlled forms for completeness and accuracy.• Conducts approval of pre-start-up manufacturing activities including line/room clearance, and initial equipment checks.• Reviews in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company Standard Operating Procedures (SOPs) and cGMP's.• Provide real time guidance to line operations personnel pertaining to compliance to cGMP's by monitoring dress code, documentation practices, testing methods, and testing accuracy Show less

• Senior Quality Assurance Lead

  • Aug 2013 - Present



Stewart's Shops Corp

• United States
• Retail
• 500 - 600 Employee

• Cashier

  • Jul 2010 - Jul 2013

  • Provide customers with fast, friendly, accurate and safe service • Process Checkout and/or Return transactions • Observe and follow all company policies and established procedures, including facility and housekeeping duties • Assist in special projects and perform other functions as assigned by supervision • Treat all co-workers and customers with fairness, dignity, and respect • Food and coffee preparation and monitoring • Stocking of merchandise to set up store for sales success Show less