• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP
• Facilitate and drive effective communication to ensure success through representation of QC team on tier meetings
• Support all aspects of New Material Introduction process ensuring effective interaction with other departments/global teams/ external contract testing labs on matters related to new material introduction, supplier changes and associated qualification
• Participate and support Internal/External Investigations
• Coordinate the creation/ update to Quality standards for raw materials and components at Carlow. Complete impact assessments for change controls related to Carlow processes
• Coordinate any efficiency/ increased Lab capability projects as detailed by Quality Control Manager
• Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility
• Coordination, ownership, and author as required for Annual Product Review
• Participate in Quality Risk Management
Experience, Knowledge & Skills
• 2-4 years of experience in a cGMP laboratory environments
• Knowledge of or previous experience in New Material Introduction process
• Proficiency in Microsoft Office and job related computer applications required
• Good communication, interpersonal skills and ability to work across teams
• Demonstrated ability to drive the completion of tasks
• Demonstrated ability to solve problems/perform investigations
• Method validation and method transfer experience would be advantage
