Experience

Cell and Gene Therapy Catapult

• United Kingdom
• Biotechnology Research
• 200 - 300 Employee

• QA Specialist

  • Sep 2019 - Present



Ransom Naturals Limited

• QA Officer

  • Apr 2015 - Sep 2019

  Release product for the herbal pharmaceutical and food and drink industry. Also involved in internal and supplier audits. Release product for the herbal pharmaceutical and food and drink industry. Also involved in internal and supplier audits.



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Quality Associate

  • Dec 2009 - Apr 2015

  Senior Quality Associate (July 2012 – Present), QA Associate (December 2009 – July 2012) Work to GMP standards on synthetic bone graft. Responsibilities and activities include: • Review of Finished Product, Intermediates and Raw Materials to ensure they are within specification and release to customers as appropriate • Finished Product Bioburden Trending to identify any unfavourable trends; data is presented at management review • Responsible for raising and investigating NCRs including for stability, Raw Materials and Finished Product • Scheduling and delegation of QC checking activities for finished product to enable release within target dates • Raising of Hold Notices to place any batches on hold which are off-site • Performing documentation updates for all documents within the quality system • Attend a number of meetings at site and corporate levels including Monthly NCR and TrackWise meetings, Weekly Production meetings, Daily Supply Chain / Production meetings and Quarterly Communication meetings • Involved in a number of projects as QA contact, including stability for several product lines, Line-side Labelling for finished product, Scrapping process improvements, Item Certification and Reduced Testing (to enable compliance with divisional procedures) • Performing reviews of released product for customer complaints • Performing electronic transactions within ERP (JDE - Oracle based software), including batch release, location transfers, reclassification of lots, linking of raw materials with suppliers / BOMs and lot tracing and tracking • Participating in Internal and External Audits, helping to conduct audits, writing and reviewing reports • Completed several training courses including: Introduction to ISO13485, Yellow Belt Six Sigma, External Supplier Audit, Train the Trainer, Advanced Excel Training, Technical Writing, MiniTab, COSHH and Leadership and Management (ILM) Level 3



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Analyst

  • Aug 2008 - Dec 2009

  Work to GMP standards on respiratory products. Responsibilities and activities included: • Checker in Emitted Dose, Bulk Assay, Powder Blends and Ultra Violet testing along with preparing and testing product • Changing Methanol drums to ensure methanol is available on tap when required to carry out testing • Co-ordinating Complaints to test devices when a complaint is received • Standardizing ways of working for Powder Blends and Emitted Dose • Making of Standards and mobile phase for HPLCs • Use of Smartlab software for sample preparation and write up • Use of Empower software for HPLC for running samples



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• DMPK placement student

  • Sep 2006 - Aug 2007

  Activities and training included: • Accelerated Mass Spectrometry sample preparation • HPLC and UPLC using Chemstation, Lablogic Laura3 and Masslynx software • Prepare samples for studies involving hepatosites and microsomes. • Completed a project involving HPLC and UPLC analysis to determine the difference between columns to ensure the best ones were used. • Completed several training courses including: GLP training, radioactivity and use of fire extinguishers Activities and training included: • Accelerated Mass Spectrometry sample preparation • HPLC and UPLC using Chemstation, Lablogic Laura3 and Masslynx software • Prepare samples for studies involving hepatosites and microsomes. • Completed a project involving HPLC and UPLC analysis to determine the difference between columns to ensure the best ones were used. • Completed several training courses including: GLP training, radioactivity and use of fire extinguishers