This position is responsible for the proper assembly of clinical supplies following the batch paperwork. The packaging technician is required to follow all applicable standard operating procedures and supervisory instructions to ensure compliance with customer specifications and cGMPS’s. This position is for employees who are capable of performing most phases of clinical packaging but still require supervision in some areas.

Essential Duties and Responsibilities:

Applies Good Manufacturing Principles in all areas of responsibility.

Demonstrates and promotes the company vision.

Reviews batch paperwork and follows supervisor instructions to understand and perform the necessary packaging procedures required for assembly of each study.

Cleans packaging rooms and machinery in accordance to Standard Operating Procedures and Good Manufacturing Principles.

Performs manual and automated filling and packaging of blistered and bottled pharmaceutical products independently and approves in-process products at other stations.

Performs and ensures proper card and drug placement using various secondary card sealing machinery.

Accepts or rejects in-process clinical supplies according to acceptability standards determined by Good Manufacturing Principles, customer requirements, and Standard Operating Procedures.

Labels and assembles both blinded (following a randomization schedule) and open clinical supplies in conjunction with other FCS personnel ensuring proper label placement.

Accurately counts out and prepares packaging supplies to ensure proper accountabilities prior to and at the completion of a job order. Assists Quality Assurance personnel, Production Supervisors and Line Leaders in staging and reconciliation of components as required.

Performs final check of work in-process and finished products and then packs these goods into appropriately labeled containers.

Assists in staging and reconciliation of components as required.

Conducts all activities in a safe and efficient manner.

Other duties may be assigned to meet business needs.