Quality Control Specialist

• 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, and 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 the 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 authorship as required for Annual Product Review.
• Participate in Quality Risk Management.
Experience, Knowledge & Skills• 2-4 years of experience in 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 and interpersonal skills with the ability to work across teams.
• Demonstrated ability to drive the completion of tasks.
• Demonstrated ability to solve problems and perform investigations.
• Method validation and method transfer experience would be an advantage.

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