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Sunday, December 10, 2017

QC Micro Analyst | US Pharma Start up

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Role Description

QC Micro Analyst- US Pharma Start up- Westmeath
My client, a clinical- stage pharmaceutical company, are looking for QC Micro Analyst to perform environmental monitoring, water testing, microbial testing of raw materials and in process samples.
The Job

Overall Purpose:  

QC Micro Analyst performs environmental monitoring, water testing, microbial testing of raw materials and in process samples. The QC Micro 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 sterile manufacturing.

Essential Duties, Functions and Responsibilities:
  • Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety and is diligent in the use of all appropriate safety tools, PPE and permits when sampling or when testing in the laboratory. Maintains a high standard of housekeeping within the Laboratory.
  • Performs environmental monitoring, water testing and associated microbial testing including
endotoxin, bioburden testing, TOC/conductivity testing, growth promotions, bacterial identification and biological indicator testing.
  • Actively participates and can lead laboratory investigations using structured problem solving processes.
  • Develops lab procedures and supports site procedure development as required.
  • Executes validation protocols for process validation and method validation.
  • Reviews laboratory data and documentation as assigned.
  • Daily up-keep and maintenance of Laboratory Equipment.
    • Develops and leads GMP sterility assurance training and micro awareness training to site personnel.
    • Participates in bi-annual media fill studies to maintain line qualification status.
    • Is diligent in the completion and review of batch and testing documentation required to meet cGMP requirements. Accuracy and timely recording of all GMP information is particularly importance in a GMP laboratory.
      • Is always prepared to escalate any safety, quality or performance risk observed.
Skills/Knowledge Required: 

  • Experience in microbiological testing of sterile drug product and of associated environmental and utilities.
  • Experience in Method Validation.
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting commercial manufacturing.
  • Experience in Quality Risk Management.
Education Required:
  • Degree in Microbiology
Experience Required:
  • Minimum of 5 years of experience in cGMP Quality Control Micro Laboratory environment.

Work Environment/Hazards and Physical Demands:
There is high physical demand in this role due to the nature of sampling, supporting manufacturing in cleanroom environments and testing in a laboratory using isolators, etc.
While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls and to sit, talk, see, and hear.  The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 5kg.  The employee is occasionally required to crouch. The employee will be expected to wear protective and/or safety equipment as needed.
This role is likely to be a role on a regular day shift but it is possible that this role is a shift role and the successful candidate will be expected to work on the shift pattern determined by the site.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skills and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The role will typically require infrequent, off site national and international travel, for training or new equipment testing, including overnight stays, up to 10% of the time.