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QC Microbiology Analyst - SHIFT - Dublin

  1. Dublin
  1. Contract
Competitive
25802WP/Shift
  1. Compliance / Quality Assurance
Date Posted17 Nov 2020

QC Microbiology Analyst - shift - 6 months + 

Newly fitted out Drug Substance facility have a contract requirement for an experienced QC Microbiology Analyst.

The role:
You will be required to qualify the Micro QC lab and transfer of microbiological anaytical methods to more cutting edge rapid microbiological methods, ensuring the lab testing for process is streamlined.

Activities within the role:

  • Perform and carry out a variety of routine microbiological analytical techniques including environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.
  • To integrate and complete all documentation on time and be familiar with LIMS
  • Trained in the use of Rapid microbiology techniques including endotoxin testing, water bioburden testing, E.M testing, absence of bioburden testing and identification testing.
  • Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  • To update SOP’s and write protocols as required.
  • Support the laboratory testing schedule to achieve an efficient QC system.
  • Receive and manage samples that come into the lab for stability, in-process and release testing.
  • Calibrate and maintain all designated laboratory instruments.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Ensure that cGMP standards are maintained at all times.

 Qualifications, Skills & Experience Required : 

  • Degree qualification (Science/Quality/Technical).
  • Preference Lean Six Sigma

Experience:

  • 1-3 years industry experience with significant knowledge and experience in working in a microbiology lab unit and working with contract labs.
  • Experience in compendial testing for water and environmental monitoring in clean room environments.
  • Working knowledge of QC Systems (Empower, LIMS, Trending systems.)

Skills:

  • Good aseptic technique and awareness of contamination control.
  • Good verbal and written communication skills.
  • Troubleshooting and problem-solving skills.
  • Good attention to detail/strong organisational skills

Shift Pattern: 24/7 - 4 Shift Cycle (Days & Nights) 06.45am-7pm; 6.45pm-7am

  • 33% shift uplift for Shift.


Call me for further information on this role!

 



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