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QC Micro Analyst - Ireland  

Alexion (company)


Posted on : 19 June 2017

Project Description

 Position Summary
  • The QC Microbiology Analyst will follow written procedures and protocols, as trained, to perform environmental monitoring, water testing, microbial testing of raw materials and in process samples. The QC Microbiology Analyst will be responsible for the execution of validation/qualification protocols.
  •  The QC Microbiology Analyst is required to work in a GMP environment meeting all expectations associated with the support of the sterile fill finish.  .

Principal Responsibilities
The successful candidate will be responsible for:
  • Environmental monitoring, water testing and all associated microbial testing as follows;
    • Endotoxin testing, Bioburden testing, TOC/Conductivity testing, growth promotions, bacterial identification and Biological Indicator testing.
  • Preparation and testing of both in-process and finish product samples in accordance with written procedures and best practices.
  • Perform practical work accurately and precisely.
  • Accurate and timely recording of all information pertinent to the task being performed in the relevant Laboratory Worksheets / Notebooks and LIMS.
  • To review and check own work results for accuracy and presentation.
  • Participate and compile Laboratory investigations using Root Cause Analysis tools.
  • Write and revise Procedures, deviations, CAPA, Change Controls and technical investigations and reports as assigned.
  • Participate in Quality Risk assessments as required.
  • Execution of validation protocols for process validation and method validation.
  • Review of laboratory data and documentation as assigned.
  • Ensuring training is current for all job function performed and attend all company training as required.
  • Train and mentor other analysts/personnel as required.
  • Daily up-keep and maintenance of Laboratory Equipment.
  • Organize/plan/Schedule daily work schedules for assigned work /Equipment calibration or as part of a specific project using lean lab concepts.
  • Responsibility for ordering of Laboratory Consumables and maintain sufficient stock levels.
  • To maintain a high standard of GMP/GLP in the Laboratory.
  • To maintain a high standard of housekeeping and Safety within the Laboratory.
  • To adhere to all Safety / Dress Code procedures.
  • Perform and assist in additional duties.
  • To report to and be directed by the Laboratory Management.

  • Experience in cGMP Quality environment
  • Experience in testing of sterile drug product and aseptic filling process of pharmaceutical /biopharmaceutical products.
  • Experience in Method Validation
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
  • Experience in Quality Risk Management 

Degree in Microbiology or related science. 

About Us: 
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.  
  • As the global leader in complement inhibition, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.  
  • Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders 
  •  In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.