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Quality Assurance Specialist

  • Job reference: 925647
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 23/05/2019

Orion Group is recruiting a Quality Assurance Specialist on behalf of our Biotechnology Client based in Dun Laoghaire - 12-month contract Initially

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 internally 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 decision-making principles
* Drive continuous improvements and first mindset
* Demonstrate ownership for required training on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)
* Engage &/or to 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.

Authority
* 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 the 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 the time to domestic and international sites


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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