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Packaging Technician
Ref No.: 18-28460
Location: Indianapolis, Indiana
Position Summary: 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. 
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 or automated filling and packaging of blistered and bottled pharmaceutical products with another technician (Packaging Technician Level II or above) inspecting the clinical supply prior to bulk packing and its release.
•             Performs and ensures proper card and drug placement using various secondary card sealing machinery with another technician (Packaging Technician Level II or above) inspecting the clinical supply prior to bulk packing and its release.
•             Accepts or rejects in-process clinical supplies and drug products 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 another technician (Packaging Technician Level II or above) performing a double check of all their work.
•             Accurately counts out and prepares packaging supplies to ensure proper accountabilities prior to and at the completion of a job order. 
•             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.

Basic Minimum Qualifications (BMQ):     To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. 
Education/ Experience (BMQ):  High school diploma, or GED, combined with the ability to read, write and complete basic mathematics calculations.  One year experience in packaging or equivalent work experience a plus.
Add’l preferences:             
 Internal and External Contacts:  This position has internal contact with all production operation employees, engineering, inventory, and quality assurance personnel.  External contact is limited to client personnel observing packaging operations.
 Ability and/or Skills (BMQ):          This position requires hand-eye coordination, manual and finger dexterity, attention to detail, and the ability to do repetitive tasks and learn new ones with assistance from supervisors and fellow employees.  In addition, accurate counting and understanding of batch paperwork is necessary to ensure proper assembly of clinical studies.

Add’l preferences:         
Work Schedule: Evenings (2:45pm-1:30am)              
Other Factors:  
•             Dexterity and ability to perform limited packaging operations.  Long periods of standing while working in rooms.  Exerting up to 25 lbs. of force occasionally and/or 10 to 25 lbs. of force frequently to move objects.  Will need to wear personal protective equipment such as respirators, coveralls, and protective eyewear as required.
•             Allergies to specific drugs, like penicillin and cephlasporin, may disqualify individuals from performing these duties.

Ruchit Patel
703 889 6825