Quality Operations Technician Dundalk
Core
Sample, approve, and release incoming goods, packaging materials, and products for use in production within a biopharma manufacturing environment.
Role type
Quality Operations Technician
Builds
Incoming goods, packaging materials, and products for biopharma clients
Domain
Biopharma / Manufacturing
Required skills
Sampling, Certificate of Analysis (CoA) review, Supplier/Customer Defect (SCD) management, Master Packaging Material Specifications review, CAPA management, cGMP compliance, Housekeeping audits, Validation study assistance
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); Ensure compliance with current Good Manufacturing Practice (cGMP) requirements; Assist in validation studies as required.
Seniority
Individual Contributor