Job Type: Contract
Job ID: JO-1901-12258
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 email@example.com 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: Reagent management / HPLC mobile phase preparation, GMP document review and management, sample and data management and some analytical testing.
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 tasks with efficiency and accuracy.
Review, evaluate, back-up/archive, and approve analytical data.
Troubleshoot, solve problems and communicate with stakeholders.
Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
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.
HPLC experience is essential
Bachelor’s degree in a science discipline.
1-2 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 cGMP manufacturing and testing of pharmaceutical products.
Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Some / limited experience in a wide variety of analytical techniques including but not limited to Capillary Electrophoresis, Gels or HPLC.
Excellent verbal and written communication skills
Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
Demonstrated ability to work independently and deliver right first time results
Works under minimal direction
Refers to technical standards, principles, theories and precedents as needed
Demonstrated leadership and communication skills
Auditing documentation and operation process
Demonstrated ability to interact with regulatory agencies
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 firstname.lastname@example.org or call +353-1-7978720
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