This position is for the 2nd shift. Typical hours are M-F 3:00 PM-11:30 PM.  
This position is eligible for a Shift Differential.

Job Summary

Participates within the operation of packaging and labeling and using equipment of varying complexity and in accordance with Production Manufacturing records, applicable SOPs, and ISO and cGMP requirements to produce intermediates and final kits. 

Responsibilities

• Assembles totes, cartons, platforms, and associated packaging and filling components. Under direction of area supervision, assist in setting up Packaging lines, and staging for production activities.
• Perform visual inspection for visible defects of components being placed into kits in the Packaging Area.
• Place components (filled vials, inserts, barcode clips etc.) into totes and or kits per instructions in applicable SOPs and Production Records.
• At conclusion of Fill/Pack operation, count and reconcile intermediates, labels, inserts, etc.
• Palletize finish product and assist in moving production materials from Pack lines to refrigerated and general warehouse areas.
• As part of the production team, may perform in-process quality checks for specific quality attributes (vision system check, label alignment checks, kit inspections, etc.).  Inspects products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements.Make judgments regarding quality of product and materials.
• Assists in completing all necessary documentation (Production Manufacturing Records, electronic batch records, required forms, etc.) associated with packaging operations as required.
• Assists in MRP system transactions to ensure corresponding process orders are timely completed.
• Cleans work area and decontaminates work surfaces in accordance with defined procedures, and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements.
• As required, performs warehousing activities according to defined procedures, which may include picking, issuing returns, internal distribution of goods, receiving, and shipping.
• Job requirement will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls. 

Education

• Required: High School Diploma                   
• Preferred: High School Diploma and experience in medical device or related industry.     

Experience

• Required: 0-2 years experience  in an "Operations/Production environment " or filling, labeling or warehouse operations or equivalent combination of education and experience
• Preferred: 6 months’ experience in in a pharmaceutical or medical device industry.
• Equivalent combination of education and work experience.