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University of Rochester Clinical Research Packaging Technician IV - 235002 in Rochester, New York

Clinical Research Packaging Technician IV Job ID 235002

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 079 Neuro-Ctr Human Exp Ther/CMSU

Schedule

8 AM-5 PM; OCC WKENDS

Responsibilities

GENERAL PURPOSE:

In addition to being able to satisfy all of the requirements associated with the Laboratory Technician III position, the incumbent in the Laboratory Technician IV position will be expected to apply their extensive current Good Manufacturing Practices (cGMP) experiences along with strong critical thinking skills to handle responsibilities of a more complex nature within the Clinical Materials Services Unit (CMSU). Those responsibilities are delineated in the table below:

DESCRIPTION OF RESPONSIBILITY:

  • Provide quality, timely, consistent clinical trial drug and device packaging in strict compliance to current Good Manufacturing Practices (cGMPs).

  • Organize and maintain a cGMP compliant storage and processing area within the CMSU facility.

  • Determine departmental needs and order all packaging components critical to the assembly of finished study drug/device kits/packages from approved vendors.

  • Organize and maintain a cGMP compliant storage facility.

  • Maintain a cGMP compliant system for the return and accounting of all returned investigational products.

  • Generate, organize and maintain documents in compliance with requirements of cGMPs.

  • Handling of drugs, devices and components in accordance with cGMPs during receipt, warehousing, processing, distribution, return and destruction.

  • Follow-up with clinical trial sites in response to inquires and resolve problems.

  • Execution of IQ/OQ/PQ and Production Validation Protocols for packaging equipment

  • With oversight from functional manager, generate draft version of Standard Operating Procedures (SOPs), Processing Order (POs), and Clinical Material Specification Sheet (CMSS) documents.

  • Training CMSU staff on SOPs, POs, and CMSSs

  • *Experience with handling controlled substances in compliance with NYS and Federal [Drug Enforcement Agency (DEA)] requirements.

  • Working independently to generate SOP’s, POs, and CMSS documents from draft stage through to final approved documents.

  • Development of training programs to CMSU staff

  • Participate directly in inspections by regulatory agencies and external auditors.

  • Participate in the development of packaging equipment requirements, assessment of equipment capabilities and recommendations for purchase,

  • Assume interim supervisory responsibilities.

  • Participate in development of budget worksheet in response to Requests For Proposals (RFPs).

  • Develop agenda and participate in team presentation of CMSU capabilities during meetings/teleconferences with possible new and established clients.

  • Represent the CMSU at industry conference exhibits when needed.

    • This responsibility applies in the event that the CMSU becomes registered to handle controlled substances.

    SPECIFIC RESPONSIBILITIES:

  • Processing Operations: To follow GMPs and high-quality standards in the labeling, packaging and distribution of clinical materials according to written procedures. Must have thorough understanding of the relation of the required labeling to the overall study design. Foster an environment of continuous improvement by remaining alert to opportunities for improvement and offering suggestions. (20%)

  • Facility Operations: Organize and maintain a GMP compliant facility. Duties include shipping, receiving, accurate record keeping and routine cleaning of processing rooms and drug/device and component storage areas. (20%)

  • Inventory Control: Anticipate departmental needs based on established clinical plans for the ordering of all packaging components critical to the assembly of finished study supplies. Make necessary adjustments to computer-based inventories to reflect accurate stock levels. (20%)

  • Document Management: Must accurately execute and file all documentation generated in routine departmental operations. Must constantly review the necessity and effectiveness of existing forms and recommend appropriate changes, additions and deletions. (20%)

  • Response to Inquiries from Site Personnel and Resolution of Issues: Research and respond to routine inquiries from site personnel and elevate complex and/or urgent inquires to the attention of the functional manager. (10%)

  • Delivery of Project Specific Training: Deliver training to CMSU personnel involving existing processes, projects and training modules. (5%)

  • Document Generation: With oversight of functional manager generate draft versions of original and revised documents that include Clinical Materials Specification Sheets (CMSS), Processing Orders and SOPs (2.5%).

  • Execution of IQ/OQ/PQ and Production Validation Protocols for packaging equipment. (2.5%)

    Other projects and job duties as assigned.

    REQUIREMENTS:

  • Some college desirable, science related bachelor’s degree preferred, minimum 2-5 years of pharmaceutical industry experience and/or clinical trial supply experience, strong working knowledge of GMPs along with computer skills (Word, Excel)

  • Excellent interpersonal and communication skills, including written communication.

  • Ability to work well in a team environment where all work product is reviewed and approved by the Quality Assurance group before any work product leaves CMSU.

    NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.

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