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
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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