Job Type: Contract
Job ID: JO-1901-12493
Consultant: Karen McHugh
Are you a QC specialist with 3 years extensive HPLC experience with Empower software ?
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 firstname.lastname@example.org for review.
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.
3 years extensive HPLC experience with Empower software
Peer to peer review experience
3 years solid GMP pharma experience
Potential for shift cover
Experience and comfortable with general GMP IS systems, electric lab notebook, QMTS, LIMS.
Bachelor’s degree in a science discipline.
5+ 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.
Chemistry experience is preferable
HPLC experience is essential
Contract rate of €20 - €30 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 email@example.com or call +353-1-7978720
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