QC Analyst - HPLC - Amgen - Dublin


Location: Ireland

EUR 20 - 30 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1901-12500

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 karen@jobcontax.com for review.

 

QC Analyst - HPLC - 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, 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. 


Requirements 

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


Package

Contract rate of €20 - €30 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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