Job Details: QC Microbiology Analyst


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
QC Microbiology Analyst


Are you a QC Microbiology Analyst with 2+ years of experience in cGMP Quality environment ? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



QC Microbiology Analyst - Amgen



Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.



Job Description:




The QC Microbiology Analyst will follow written procedures and protocols, as trained, to perform environmental monitoring, water testing, sub - visible particulate testing, microbial testing of raw materials, in process samples and finished product. 

Principal Responsibilities 

The successful candidate will be responsible for: 

Environmental monitoring, water testing and all associated microbial testing as follows; 

Endotoxin testing, Bioburden testing, growth promotions, bacterial identification, sub-visible particulate testing 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. 

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. 

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.




 

Requirements



Degree in Microbiology or related science.  

Minimum of 2 years of experience in cGMP Quality environment 

Experience in testing of sterile drug product and aseptic filling process of pharmaceutical /biopharmaceutical products. 

Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.  

A high degree of technical competency and understanding of microbiological methods, microbiological method validation, aseptic techniques and cleanroom behavior. 

Demonstrated Teamwork and flexibility through the ability to develop collaborative relationships with other functions in order to achieve functional goals. 

Excellent problem solving and root cause analysis skills in area of expertise. 

Strong organizational skills. 

Demonstrated accountability through the planning/scheduling of own work. 

Good written and oral communication skills.


 
Package:

14 month minimum contract

Rate: €25 per hour



Contact

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720

Click to connect with Karen on LinkedIn



Similar Jobs

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Amgen Jobs

QA - QC

Are you a QC Microbiology Analyst with 2+ years of experience in cGMP Quality environment ? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



QC Microbiology Analyst - Amgen



Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.



Job Description:




The QC Microbiology Analyst will follow written procedures and protocols, as trained, to perform environmental monitoring, water testing, sub - visible particulate testing, microbial testing of raw materials, in process samples and finished product. 

Principal Responsibilities 

The successful candidate will be responsible for: 

Environmental monitoring, water testing and all associated microbial testing as follows; 

Endotoxin testing, Bioburden testing, growth promotions, bacterial identification, sub-visible particulate testing 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. 

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. 

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.




 

Requirements



Degree in Microbiology or related science.  

Minimum of 2 years of experience in cGMP Quality environment 

Experience in testing of sterile drug product and aseptic filling process of pharmaceutical /biopharmaceutical products. 

Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.  

A high degree of technical competency and understanding of microbiological methods, microbiological method validation, aseptic techniques and cleanroom behavior. 

Demonstrated Teamwork and flexibility through the ability to develop collaborative relationships with other functions in order to achieve functional goals. 

Excellent problem solving and root cause analysis skills in area of expertise. 

Strong organizational skills. 

Demonstrated accountability through the planning/scheduling of own work. 

Good written and oral communication skills.


 
Package:

14 month minimum contract

Rate: €25 per hour



Contact

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720

Click to connect with Karen on LinkedIn



Similar Jobs

Jobs in Dublin

Amgen Jobs

QA - QC

We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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