Experience

Tcoag

• Ireland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QC Biochemist

  • Jan 2017 - Present

  - Testing of in-vitro diagnostic products according to Quality Test Methods. - Microbiological testing of water system and in-process solutions. - Raw Materials testing - Testing of Pilot & Verification batches as per Continuous Product Improvement (CPI) Protocols. - Conducting Out-Of-Specification (OOS) Investigations. - Performing Long Term Stability (LTS) testing. - Batch paperwork reviewer. - Change Controls reviewer. - Spreadsheet and Product Lot Specifics Validation. - Process trending analysis. - Supporting Right First Time (RFT) for the QC group. - Awareness of Departmental Key Performance Indicators. - Managing QC Reference Materials - Completion of documentation to cGMP standards. - Completion of Certificates of Analysis. - Ensuring QC analyzers are maintained and calibrated as per Equipment Operation Procedures. - Maintaining and adhering to laboratory 5S standards. - Training of colleagues on applicable assays/instruments. - Ensuring training compliance for all relevant company polices and procedures. - Complying with company Health & Safety procedures. Show less



Diasorin

• Italy
• Biotechnology Research
• 700 & Above Employee

• Technical Support Scientist

  • Mar 2012 - 2016

  - Technical Support to Production and QC. - Managed internal investigations of technical issues in Production and QC. Data analysis, design of experiments to identify root cause and implementation of corrective actions. - Customer support.- Managed external investigations of technical issues.- Process improvements. Investigated anomalous trends in the manufacturing processes and instigated improvements. - Test method improvements which included the validation of a new test method to address a CAPA which required a 30 day supplement for the FDA.- Participated in FDA audits.- CAPAs.- Design Changes.- Change Controls.- Training of colleagues on applicable assays/instruments. Show less

• Production Scientist

  • Nov 2011 - Mar 2012

  - Manufacture and testing of ELISA products.- Stock control of raw materials and laboratory consumables.- Equipment maintenance and calibration.