Senior Micro QC Analyst (Sterility)

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Job Description

This role needs someone who is an expert in sterility testing (direct inoculation and membrane filtration using an isolator).  They will need to be able to demonstrate sterility testing in front of auditors.

Job description 


• Technical support with regard to method validation and isolator technology
• Validation/ Qualification of microbiology test methods such as sterility and Endotoxin testing
• Training and development of laboratory personnel
• Develop and updating of laboratory documentation
• Represent microbiology department in internal and external Biologics audits where appropriate
• Investigate out of specification results utilising structured problem-solving skills in conjunction with relevant departments in order to implement effective preventative actions and closing out of investigation in timely manner
• The analysis of raw materials, in process and finished products
• Reviewing analytical data, analytical reports and performing peer reviews
• Analytical method transfer and compendia verification

Requirements
• Minimum of a Bachelor of Science Degree

Minimum of 3 years relevant experience in a microbiology laboratory environment

• Experience of Endotoxin and sterility testing of biopharmaceutical products would be an advantage

• Technical competency and experience of front-line regulatory interaction (e.g. HPRA, FDA,)

•Experience in Raw material and Release testing

• Experience in Method Validation/Transfer/Verification

• Strong knowledge in operation and qualification of lab equipment (IQ/OQ/PQ)

• Must have effective problem-solving skills

• Self-motivated and able to prioritize

• Proficiency in speaking, comprehending, reading and writing English is required

Apply via LinkedIn

Damilola Durowoju

Recruitment Consultant +353 1 9476360 Damilola.durowoju@cpl.ie
  • Salary:Negotiable
  • Location:Dublin City Centre
  • Type:Permanent
  • Category:Science
  • Ref.no:JO-2004-449342_3