Job Type: Contract
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 email@example.com for review.
QC Analyst - Microbiology - Amgen - Dublin
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.
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
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
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
Contract rate of €20 - €25 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail firstname.lastname@example.org or call +353-1-7978720
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