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Experienced Technical Writer with a Degree in Genetics. Currently working for a Medical Device Company experienced with ISO9001, ISO13485, FDA 21 CFR and the IVDD. Good working knowledge of cGDP, cGLP and cGMP. Also experienced in Statistical Analysis using Microsoft Excel, R and Python.
$45 USD/hr
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  • 100%Trabalhos concluídos
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  • imagem de Jeff C. scientific MSDS made for our products $100.00 USD

    “I was impressed with how quickly Joe finished the job and responded to my questions and changes that I needed done. I am definitely keeping his contact information.”


Process Development Associate III

Apr 2014

Technical Assistant

Apr 2013 - Apr 2014 (1 year)

Worked within the Product Development Late Phase and Transfer Team to support the Verification and Transfer activities for PMA and 501(k) FDA approved products. Skills developed include: • Quality Management System – Extensive understanding of working within a quality management system that conforms to the ISO13485 standards and the FDA 21 CFR §820. Including authoring critical SOPs for Goods Receipt and Process Validation. • Design Controls – Contributed to the Design History File for FDA PMA and 501(k) approved products, by authoring deviations including those classed as ‘serious’, and producing tables for the inclusion in reports. Author design Device Master Records. • Troubleshooting – Conducted detailed investigation and reporting to find root causes in equipment faults, followed by finding solutions that ensure timelines are not greatly affected. • Regulatory Affairs – Assisted closely in customer, TUV and FDA audits, giving me a good appreciation of an auditors thought process and the potential problems that can arise within a quality system.

Testing and Validation Technician

Oct 2011 - Apr 2013 (1 year)

In charge of testing all new product prototypes to ensure they meet the required specification. This includes writing Validation Testing Specifications for all products and developing the tests and experiments to do so. Skills developed include: Extensive Lab Skills – Conducted over 300 PCR trials using the thermal cycler to test the high- throughput capabilities. Also, conducted real-time PCR to test the Quantica real-time PCR cycler. Accurate Documenting – Kept detailed research standard lab book, to provide hard data on the efficiency and effectiveness of the thermal cycler. This included photographic documentation of the physical wear and tear on recommended consumables. Report Writing – Presented weekly the results of tests on the thermal cycler to the Development meetings, this included presenting my results to a number of the Directors of Bibby Scientific Ltd. Project Planning – Planning the testing schedule to ensure that testing is done on all projects to keep in line with the rest of the company’s schedule.


BSc (Hons) Genetics

2007 - 2011 (4 years)


  • US English Level 1


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