QC Analyst - Microbiology - Amgen - Dublin


Location: Ireland

EUR 20 - 25 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1812-12201

Consultant: Karen McHugh






Are you a QC specialist with experience in testing using Bioburden, Endotoxin, Sterility, Utility Sampling techniques. Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? 

If interested in this role please contact Karen McHugh to discuss in detail or send your CV to karen@jobcontax.com for review.

 

QC Analyst - Microbiology - Amgen - Dublin

 

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

Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers and verification, 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. 

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, complex routine/ non-routine methods and procedures and a large variety of assays. 

Report, evaluate, back-up/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 and equipment qualification/verification. 

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. 

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 


Requirements 

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 

This is a bench testing role using Bioburden, Endotoxin, Sterility, Utility Sampling techniques. 

Candidates ideally need all but HM is happy to look at candidate with some of these techniques Candidates must come from the pharma or bio pharma sector

Preferred Qualifications 

Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling. 

Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning 

Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery 

Excellent verbal and written communication skills 

Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) 

Ensures compliance within regulatory environment 

Able to use statistical analysis tools to perform data trending and evaluation 

Project Management and organizational skills, including ability to follow assignments through to completion 

Technically strong background in microbiology and aseptic manufacturing 

Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage 

Experience with Regulatory inspectors and interacting with inspectors desirable 

Auditing documentation and operation process 


Package

Contract rate of €20 - €25 per hour

Minimum 12 month contract

 

Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or call +353-1-7978720

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