Quality Control (QC) Systems Specialist

Orion Group Life Sciences are currently recruiting a Quality Control (QC) Systems Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 12-Month contract with potential to extend.
 
Role Description

• The Quality Control (QC) Systems Specialist supports the QC Laboratory through routine maintenance, troubleshooting and repairs of all analytical laboratory instruments, in addition to supporting the instrument lifecycle (installation, qualification, operation, and retirement).
• Additionally, the QC Systems Specialist supports the management of software application such as Empower, LabX and Signals, and any requests relating to these systems.
• The QC Systems Specialist leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise.

 
Role Functions
(Functions include, but are not limited to, the following)
The QC Maintenance Instrumentation Specialist roles and responsibilities include but are not limited to the following:

• Responsible for the planned and unplanned maintenance of the QC systems and instrumentation, in compliance with up-to-date data integrity, regulatory, and industry standards
• Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
• Serve as site co-ordinator for software applications such as Empower, LabX and Signals.
• Support the QC department as a Super User and complete method requests as required.
• Support the QC department for troubleshooting, investigations, and deviations as an SME.
• Manage deviations, CAPA’s and change control’s related to QC systems and instrumentation and team priorities.
• Author and revise local SOPs, work instructions, and guidelines.
• Serve as an SME for regulatory and internal inspections and audits.
• Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.

 
Experience, Knowledge & Skills
Technical:

• Strong experience with analytical instrument maintenance, CSV experience beneficial.
• Experience using software applications such as Empower.
• Excellent understanding of data integrity compliance requirements.
• Demonstrated ability to drive complex tasks to completion.
• Strong organizational, problem-solving, and continuous improvement skills.

 
Business:

• Ability to prioritize activities in line with the maintenance schedules and business needs.
• Ability to maintain the flexibility to react to changing business needs and priorities.
• Experience and understanding of the change management requirements of validated systems and software.
• Excellent communication skills both verbal and written.

 
Leadership:

• Ability to handle multiple projects and deliver on critical deadlines.
• Demonstrated ability to work independently on own initiative and manage time.
• Demonstrate ability to work with a team and co-ordinate work to meet a common goal.
• A high level of self-motivation, knowledge, enthusiasm, and drive.

 
Qualifications

• Third level education in a Science or Engineering related course of study

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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.