Join Charles River Labs in Rathcoole, Co. Dublin D24 NF21 as a Quality Assurance Supervisor. Lead a team of QA specialists to ensure products, processes, and services meet established quality standards and regulatory requirements.
Requirements
- Manage activities of assigned group(s) to ensure optimum performance of the team and meet business needs and timelines.
- Supervise, mentor, and develop a team of QA specialists.
- Promote a culture of quality, accountability, continuous improvement, and operational excellence.
- Oversee inspection, testing, auditing, and documentation activities related to product or service quality.
- Ensure adherence to internal SOPs, industry standards, and applicable regulatory requirements (e.g., ISO, GMP, GDPR).
- Review and approve QA documentation, including quality reports, deviations, CAPAs, and inspection records.
- Monitor and analyse quality metrics to identify trends, risks, and opportunities for improvement.
- Develop, maintain, and enhance efficient work procedures and processes aligned with company standards and quality directives.
- Act as lead host for client site visits and regulatory inspections, managing communications, inquiries, and all audit-related activities.
- Develop corrective and preventive actions (CAPAs) in response to client and regulatory findings and coordinate drafting of follow-up correspondence with affected departments and report outcomes to senior management.
- Review and approve SOPs, protocols, batch records, reports, and other regulated records (e.g., deviations, change controls, CAPAs) involving technically complex processes to ensure accuracy and compliance.
- Lead the execution and scheduling of internal facility inspections to evaluate the effectiveness of site quality systems.
- Support the review, negotiation, and maintenance of Customer and Supplier Quality Agreements.
- Provide QA support for validation activities, including computer systems, controlled environments, test methods, and manufacturing equipment.
- Facilitate, host, and present at Quality Management Review (QMR) meetings.
- Participate in and/or lead QA-related projects and cross-functional continuous improvement initiatives.
- Ensure timely resolution of non-conformances and effective implementation of corrective and preventive actions.
- Maintain accurate and compliant quality records and ensure the team adheres to controlled document processes.
- Ensure site compliance with applicable regulations and corporate policies; escalate identified quality or compliance risks to management.
- Collaborate closely with Operations, Laboratories, Customer Service, Facilities Product, Compliance, and other functions to ensure quality standards are embedded across workflows.
- Lead or support continuous improvement activities to enhance quality operations, efficiency, employee engagement, and service to internal and external customers.
- Communicate quality issues, insights, and recommendations effectively to stakeholders.
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Retirement Plan
- Generous Paid Time Off
- Tuition Reimbursement
