QC Specialist
Core
Lead and mentor the Sample Management Team to ensure compliance, safety, and reliable customer supply for vaccine and biologic products at the Carlow site.
Role type
Senior IC QC Specialist (Sample Management)
Builds
Vaccine and biologic drug products
Domain
Pharmaceutical manufacturing (Biologics/Vaccines)
Required skills
CGMP/GDP compliance, Data Integrity (ALCOA+), Quality Management Systems (QMS), Sample Management, Task Allocation, Technical Procedures, Continuous Improvement
Preferred skills
Leadership, Team Management, Cross-functional collaboration, Lean project management
Technologies
None explicitly stated
Responsibilities
Lead and mentor the Sample Management Team; Drive CGMP/GDP compliance in daily activities; Ensure adherence to ALCOA+ data integrity principles; Escalate potential violations affecting product safety/efficacy; Provide quality support for new product introductions; Monitor Quality Management Systems and generate performance reports; Liaise with Quality/Business specialists to resolve queries; Participate in internal and external audits; Develop cross-functional relationships for manufacturing/testing compliance; Schedule daily/weekly tasks for the Sample Management team; Support daily troubleshooting for the team.
