Quality Operations Technician Dundalk
Core
Sample, approve, and release incoming goods and packaging materials for biopharma production while ensuring compliance with cGMP and safety standards.
Role type
Quality Operations Technician
Builds
Incoming goods and packaging materials for biopharma production
Domain
Biopharma / Quality Operations
Required skills
Sampling and release of materials, Certificate of Analysis (CoA) review, Supplier/Customer Defect (SCD) system management, Master Packaging Material Specification approval, deviation and CAPA investigation, housekeeping audits, validation study assistance, safety compliance
Preferred skills
None stated
Technologies
None stated
Responsibilities
Sample, approve, and release incoming goods and packaging materials; Request and review Certificates of Analysis (CoA) / Certificates of Conformance (CoC); Manage the Supplier/Customer Defect (SCD) system; Review and approve Master Packaging Material Specifications; Raise, investigate, and close deviations and Corrective and Preventive Actions (CAPA); Conduct housekeeping audits and prepare reports; Assist in validation studies; Ensure safe work practices and report safety issues.
Seniority
Individual Contributor
