QC Lab Systems Specialist

Summary:
A biotech company in West Cork requires a QC Lab Systems Specialist.

Responsibilities:

• Responsible the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards.
• Accountable for change control process and mechanisms required to maintain a state of continued compliance for the QC systems.
• Support instrumentation or software troubleshooting, investigations, and deviations as a lab systems SME.
• Manage deviations, CAPA’s and change control’s related to the QC and team priorities.
• Serve as an SME for regulatory and internal inspections and audits.
• Provide technical expertise and coaching to support lab operations.
• Lead the delivery and of projects whilst adhering to project timelines through the use of project management tools.
• Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.

Qualifications & Experience:

• A bachelor’s degree in Engineering, biological science, or related field.
• Strong CSV experience with analytical instrument qualification and computer systems implementation.
• Excellent comprehension of data integrity compliance requirements.
• Demonstrated ability to drive complex tasks to completion.
• Strong organizational, problem-solving, and continuous improvement skills.
• Ability to prioritize Lab Systems activities in line with the project schedules and business needs.
• Ability to maintain the flexibility to react to changing business needs.
• Experience and appreciation of the change management requirements of validated systems and software.
• Excellent communication skills both verbal and written.