Sr QC Micro Associate – Days

Desired Skills: bioburden,endotoxin,microbiology

PE Global are currently recruiting for a QC Micro – Days role to be based in our Bio client site in South Dublin on a 12 month initial contract:

Job Description:

Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required. 

Job duties are as follows but not limited to: 

• Endotoxin testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug product samples
• Sterility testing
• Water sampling
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
• Writing technical reports
• Media fill reconciliation and inspection
• Weekend bioburden cover
• Perform analytical testing as a main priority with efficiency and accuracy 
• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays. 
• Report, evaluate, archive, trend and approve analytical data. 
• Troubleshoot, solve problems and communicate with stakeholders. 
• Initiate and/or implement changes in controlled documents. 
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope. 
• Write protocols and perform assay validation. 
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols. 
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis. 
• Review and Approve lab results 
• May participate in lab investigations.
• May provide technical guidance. 
• May train others. 
• May contribute to regulatory filings. 
• May represent the department/organization on various teams 
• May interact with outside resources 

Basic Qualifications: 

• Bachelors degree in a science discipline 
• Biopharmaceutical QC experience in a microbiology lab 
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products 

To apply, please call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***