Anna Kozaczek

Quality & Regulatory Lead at PolyPhotonix
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Location
UK
Languages
  • English -
  • Polish -

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Experience

    • United Kingdom
    • Medical Device
    • 1 - 100 Employee
    • Quality & Regulatory Lead
      • Jul 2019 - Present
    • United Kingdom
    • Medical Device
    • 1 - 100 Employee
    • Technical, Quality & Regulatory Scientist
      • Aug 2015 - Present
    • United States
    • Retail
    • Quality Improvement Manager
      • Oct 2008 - Mar 2014

      04/2012 – 03/2014: Quality Improvement Manager, QC Dept. Managing QC workload and improving workflow. Signing off immunoassay batch records and test results ready for sale. Coordinating inter-departmental meetings to find solutions for products with problems and arrange testing of newly developed product. Data analysis and trending of large amounts of data. Writing and amending product specifications, SOP’s, and coordinating staff training. Working with QA in ISO 9001:2000 and ISO 13485:2003 compliance issues and audits, and US FDA inspections. Implementing CAPA. Health & Safety team member. 04/2011 – 04/2012: Process Improvement Officer, QC Dept. Seconded to Quality Control Department as Process Improvement Officer to develop and implement procedures in support of a rapidly growing department 07/2009 – 04/2011: Technical Support Coordinator, Sales Dept. Providing technical support for customers worldwide, for manual and automated immunoassay products. Processing and resolving complaints, to ensure customer satisfaction. Investigating suspected kit issues in the laboratory and with other relevant departments. Providing IDS internal and customer training for all products. Visiting customer sites to support. 10/2008 – 07/2009: Validation Technician, R&D Dept. Validation of Vitamin D and Bone Alkaline Phosphatase immunoassay products. Laboratory testing and report writing. Troubleshooting through data analysis.

    • Food Production
    • 1 - 100 Employee
    • Shift Manager
      • Apr 2008 - Aug 2008

      Managing teams of staff in the packing of fried fish products, and overseeing the coating and frying process. Managing teams of staff in the packing of fried fish products, and overseeing the coating and frying process.

    • 1 - 100 Employee
    • Trainee Store Manager
      • Aug 2007 - Apr 2008

      Learning all aspects of running a retail operation. Learning all aspects of running a retail operation.

    • Papua New Guinea
    • Food & Beverages
    • 100 - 200 Employee
    • Area Manager
      • Mar 2004 - Aug 2007

      10/2005 – 08/2007 After management restructure, promoted to Area Manager, responsible for a large team in the production, packing and labelling of freshly prepared chilled fruit products. Also part of Health & Safety and Quality auditing teams. 07/2005 – 10/2005 Acting Despatch Manager. Also selected to manage and maintain specific essential production and machinery (jelly and Isheda operations) throughout move to new premises. 06/2005 – 07/2005 Temporary Training and Recruitment Co-ordinator, writing and developing SOP’s, and training staff on machinery before the factory move. Also recruiting new staff to boost each shift to target staffing level. 03/2004 - 06/2005 Employed as Graduate Trainee Assistant Department Manager, working on various projects in the factory and covering Department Managers’ holidays and absence.

Education

  • Northumbria University
    Bachelor's Degree, Applied Biology
    2000 - 2003
  • Framwellgate Moor Comprehensive School, Durham
    A-levels

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