Job Type: Contract
Job ID: JO-1908-19233
Consultant: Karen McHugh
Are you a QC analyst with 3+ years HPLC experience in a GMP Lab?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
QC Analyst - HPLC - 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, responsible for one or more of the following activities in QC including analytical testing, characterization, method development, sample and data management and equipment maintenance.
Contributes to team by ensuring the quality of the tasks/services provided by self
Contributes to the completion of milestones associated with specific projects or activities within team
This role will support manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
With a high degree of technical flexibility, work across diverse areas within the lab
Plan and perform routine analyses with efficiency and accuracy.
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.
Bachelor’s degree in a science discipline.
3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.
Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels or Capillary Electrophoresis.
Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.
Deepens technical knowledge through exposure andcontinuous 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)
Hourly Rate €25 - 35 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 him by e-mail firstname.lastname@example.org or phone +353-17978720
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