Are you a QC Specialist with experience in NPI or laboratory upgrade projects?

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 Specialist - NPI - 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

TQC Representative for site / laboratory upgrade projects

Plan and manage QC related activities from site projects.  

QC Representative for NPI activities and routine Product meetings

Plan and Perform non-core testing related to NPI activities

Manage all sample management activities related to NPI activities throughout the site Sample shipments and temperature monitoring activities for NPI activities 

Create/own and approve protocols, sample plans, SOP and documentation related to NPI  

Responsible for their own training and safety compliance. 

Assist with resource management, QC Project Management and other work streams as required by the lab management.  

Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment. Writing equipment validation protocols and associated summary reports.

Under minimal direction, functions as the specialist for non- core project team (NPI) functions and is responsible for one or more of the following activities in QC including analytical testing, characterization, sample, data management, equipment qualification and Project management. 

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 QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Specific Job Duties:

With a high degree of technical flexibility, work across diverse areas within QC 

Plan and perform analyses with great 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.

May train others as necessary

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.

May contribute to regulatory filings.

May conduct lab investigations as necessary.

Evaluate lab practices for compliance on a continuous basis.

Approve lab results 

May represent the department/organization on various teams

May interact with outside resources.

Create APPX data files and randomisation memo to facilitate data analysis. 

LIMS data coordination of commercial and import testing on site where applicable 

May provide technical guidance. May contribute to regulatory filings.

May represent the department/organization on various teams. May train others.

May interact with outside resources

Requirements 

Bachelor’s degree in a Science related field is required.  

8+ 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. 

Package

Contract rate of €40 - €45 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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