Clinical Packaging Operator Technician

Role Summary

Permanent Position - Clinical Packaging Operator Technician - 25 - CSO. Shift: 7 AM - 3:30 PM EST. Site: New Brunswick, NJ. Bldg #107 (non-excluded). Rate: $40.81 / hour. Works under direction of supervision and follows established practices in performing all duties. Requires zero error rate with multiple redundant checks; errors can have serious implications. Must document operations precisely and interface with computer-based documents and SAP. May involve handling potent compounds requiring annual gown/respirator training and medical clearance. Visual Inspection of Parenteral Products qualifications and biennial re-qualification are required.

Responsibilities

• In accordance with specific instructions, performs a variety of functions involved in the preparation of packaged clinical supplies including filling, labeling, capping, and sealing a variety of vials, bottles, unit dose blister cards, pouches or other containers prepared for use in clinical studies, clinical stability or product registration use.
• Using equipment, assembles combination products/devices to be used in clinical studies.
• Performs in process sampling during operations and records data obtained.
• Weighs and/or hand counts dosage forms and records data obtained within the appropriate documents.
• Inspect labels against label proofs and other supporting documentation for confirmation of characteristics such as count, variable text, character verification, and cosmetic defects; label inspection must be accurate with no deviations.
• Completes all documentation supporting the preparation of clinical supplies and label inspection through interface with software-based processing instructions and data collection systems.
• Performs product inspection of supplies using SAP interface or other electromechanical equipment for verifying contents.
• Performs calculations of label and product accountabilities through SAP interface.
• 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; assist with cleaning as required.
• Perform as required Visual Inspection of Parenteral Products (liquid-filled and lyophilized vials and syringes) using semi-automated or manual inspection.
• Individuals must pass inspection qualification and biennial re-qualification, including annual eye exams.
• Completes documentation supporting inspection of parenteral supplies through software processing.
• Performs other duties of equal or lesser in nature such as movement of material, organizing CSO warehouse, and general housekeeping.
• Follows CGMP, SOPs, safety rules, and housekeeping principles; interfaces with computer-based training systems.

Qualifications

• Two Year Associates degree or equivalent; in lieu of a two-year degree, minimum four years of applicable CGMP-industry experience.
• Proficiency in computer programs/systems is essential.
• Technicians must maintain skills and knowledge current with advances in Pharmaceutical Development; may attend internal or external training courses as approved.

Education

• Two Year Associates degree or equivalent; alternate may be four years CGMP experience as noted above.

Additional Requirements

• Must follow safety procedures when handling potent compounds; annual gown/respirator training and medical clearance may be required.
• Annual eye exams and biennial re-qualification are required for Visual Inspection qualifications.
• Site-essential vs site-by-design occupancy considerations; some roles require onsite work; traveling to sites or customers may be required depending on role design.