Senior QA Specialist

Dublin, Republic of Ireland
£335.76 - £344.15 per day
11 Jul 2019
25 Jul 2019
Chris Cahill
Full Time
Contract Type
Experience Level
Experienced (non-manager)


The Specialist QA is a position within the Quality Regional Work Cell in Europe reporting to the Senior Manager, QA (ESQ). The QA Specialist will be required to understand and grasp a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes. In addition to routine Quality Assurance duties, the QA Specialist may be assigned specific oversight and responsibility for key processes improvements with the Regional Work Cell and the wider External Supply Quality Organisation.
Key Responsibilities
* 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

Basic Qualifications:
* Doctorate degree OR
* Master's degree & 2 years of directly related experience OR
* Bachelor's degree & 4 years of directly related experience OR
* Associate's degree & 10 years of directly related experience OR
* High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:
* 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
* Bachelor's Degree in a Science Field
* cGMP Experience
* 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