Job Type: Contract
Job ID: JO-1908-19236
Consultant: Karen McHugh
Do you have 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry?
Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Quality Assurance Specialist - Dun Laoghaire - 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.
Manage and own NC records for External Quality
Manage and own CAPA records for External Quality
Manage and own Change Control records internal to External Quality
Manage and drive Quality records to closure independently
Perform tactical batch disposition activities in support of lot release
Provide tactical information to the networks (i.e., metrics to management, data analysis, trending, periodic monitoring, APR)
Escalate risks or roadblocks to management
Drive timely decision making using Amgen decision making principles
Drive continuous improvements and Amgen first mindset
Demonstrate ownership for required training on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)
Engage &/or participate with ongoing improvement initiatives within the Regional work cell and the wider organisation
Align and support the tools in use to manage Regional Work Cell activities including Visual management, level loading, capacity & capability management
Create and foster an environment of change and development within the Regional Work Cell and seek to influence beyond.
Create and foster key relationships to enable timely completion of activities and responsibilities.
Own Quality record content
Works under minimal direction
Identify opportunities and issues, then determine when escalation is necessary
Proposes revisions to SOPs in area of responsibility
Identifies key improvement opportunities and highlights to management
4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to oversee multiple projects simultaneously
Able to successfully manage workload to timelines
Ability to negotiate a position after taking feedback from multiple sources
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Ability to travel +/- 10% of time to domestic and international Amgen sites
Excellent Hourly Rate
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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