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 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. 

Requirements 

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

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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