Job Details
- Title: Packaging Operator
- Code: RCI-34868-1
- Location: New Brunswick New Jersey (NJ) 08903
- Posted Date: 01/13/2021
- Duration: 3 Months
Talk to our Recruiter
- Name:Mangesh Kanade
- Email: mangesh.kanade@rangam.com
- Phone: 908-704-8843 ✖ 260
- In accordance with specific instructions, performs a variety of functions involved in the preparation of packaged clinical supplies including operation of semiautomatic and automatic machines necessary for filling, labeling, capping and sealing a variety of vials, bottles, ampules, tubes, unit dose blister cards or other containers prepared for use in clinical studies, clinical stability or product registration use.
- Assembles, operates, disassembles and cleans equipment and performs routine calibration and adjustment of equipment operating parameters.
- Performs in process sampling during operations and records data obtained.
- Weighs and/or handcounts dosage forms and records data obtained within the appropriate documents.
- Inspect labels (manually and with use of electromechanical equipment) against label proofs and other supporting documentation for confirmation of but not limited to the following characteristics: Count, Variable text, Character verification and Cosmetic defects.
- Label inspection must be accurate with no room for deviations.
- Completes all documentation supporting the preparation of clinical supplies and label inspection through interface with software based processing instructions and data collection systems and use of equipment PLC’s.
- Performs product inspection of supplies using SAP interface or other electromechanical equipment for verifying contents.
- Through interface with SAP performs calculations of label and product accountabilities.
- Alerts supervision of any irregularities in procedures or equipment operations
- Makes up carriers and shippers and prepares finished supplies for shipment.
- Assist in the (re)qualification and (re)validation of processing equipment.
- Where a sterile environment is necessary, cleans and wipes ceilings, floors and walls in the prescribed manner and exposes sterile plates to monitor sterility.
- Performs other duties of equal or lesser in nature as required such as but not limited to; movement of material between work locations, organizing CSO warehouse and general housekeeping.
- Follows Current Good Manufacturing Practices, departmental SOP’s, good housekeeping principles and all safety rules.
- Interfaces with computer based applications for self-paced on line training of both company and departmental policies and procedures.
- Perform as required Visual Inspection of Parenteral Products (i.e. Liquid filled and Lyophilized vials and syringes).
- This requires individuals to pass qualification and Biennial requalification
- Education required: High school diploma or equivalent.
- Experience: one to four years applicable experience within a CGMP regulated industry
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