Seeking for a Sr. Specialist, Print Technician Team Lead position within Global Clinical Supply Operation to improve the professional knowledge and experience.
Overview
27
27
years of professional experience
Work History
Label Document Controller
Merck & Co., Inc
04.2022 - Current
Design & approve clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the Merck & Co. Inc label systems.
Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
Ensures all clinical supplies and associated documentation are processed according.
Clinical Production Supervisor
Merck & Co., Inc
04.2007 - 04.2022
Oversee daily Clinical Packaging scheduling and operation.
Assign and supervise daily Clinical Packaging operation to Clinical Packaging Technicians (CPTs) such as bottle filling (Primary packaging), vial labeling, and kit assembly (Secondary packaging).
Pre-execution of the Clinical Packaging Process Orders.
Post-reviewing Packaging Process Orders to ensure the completeness and accuracy per Packaging SOPs.
Training/ Coaching new Packaging supervisors on Pre-execution and Post-execution of Packaging Process Orders.
Supporting and training SAP to all new Clinical Packaging Technicians.
Controlled Substance SME.
NOEs and Clinical Complaints initiation and investigation.
SOPs periodic review and update
A designated SME for POMs and execution.
Participating in APRs investigation and feedback recommendation to prevent reoccurrence.
Coordinating and leading on trainings for new Clinical Packaging Technicians (CPTs) on board.
Providing On the Job Trainings (OJTs) and supporting to all CPTs on products, components, Clinical labels checking-in, quality checks, and general best practices.
Providing directions to the team of CPTs, coordinating the Packaging activities.
Performing a verification of all assigned products and components prior to the production process.
Reconciling the Clinical products and components at the completion of the Clinical Packaging Orders to ensure the completeness and accuracy.
Sr. Clinical Packaging Technician
Merck & Co., Inc
06.2003 - 04.2007
Assisting Clinical Packaging Supervisors on daily scheduling and Clinical Packaging operations.
Reviewing the Clinical Packaging Orders (CPOs) for completeness and accuracy.
POMs execution and SME POMs trainer.
Participating in APRs investigation and feedback recommendation to prevent reoccurrence.
Setting up and changeover Packaging lines and portable equipment.
Coordinating and leading on trainings for new Clinical Packaging Technicians (CPTs) on board.
Providing On the Job Trainings (OJTs) and supporting to all CPTs on products, components, Clinical labels checking-in, quality checks, and general best practices.
Providing directions to the team of CPTs, coordinating the Packaging activities.
Performing a verification of all assigned products and components prior to the production process.
Reconciling the Clinical products and components at the completion of the Clinical Packaging Orders to ensure the completeness and accuracy.
Clinical Production Supervisor
Cardinal Health Pharmaceuticals
03.2002 - 06.2003
Responsible for scheduling and production reports.
Assign daily tasks and supervise Clinical Packaging Technicians to ensure cGMPs, Standard Operation Procedures are in compliance.
Set-up, oversee the Clinical Packaging operation such as blistering packaging, card sealing, bottle filling, clinical labeling, and kit assembly.
Reconcile Clinical Packaging Orders for the completeness and accuracy.
Manage hourly unionized employees.
Experience with clinical packaging equipment such as automated conveyor fillers, blister machines, automated/ manual card sealers, induction sealers, and torque testers.
Resolved issues quickly to maintain productivity goals.
Clinical Packaging Room Leader
Omnicare Pharmaceuticals
01.1998 - 03.2002
Daily set-up the Clinical Packaging Orders for primary and secondary clinical bottle filling, blister carding, and vial labeling.
Reconcile the Clinical Packaging Orders for the completeness and accuracy.
Train & oversee of Clinical Packaging technicians daily packaging activities.