Research Packaging Coord II

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

150 Metro Park, Suite C, Rochester, New York, United States of America, 14623

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400982 Neuro-Ctr Health & Tech/CMSU

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

GENERAL SUMMARY
Possess a moderate understanding of current Good Manufacturing Practices (cGMP) as defined in 21 CFR FDA regulations and apply those to the procurement, handling, inspection, storage and processing of clinical trials supplies within the Clinical Materials Services Unit. Expected to work with some guidance in the areas generating SOP’s, Process Orders and CMSS documents. This position may sit in on client team meetings, participate in team discussion and ensure that CMSU deliverables are completed per the agreed to timelines and will keep CMSU management informed of project
progress and needed support. This position will be expected to participate in regulatory inspections and external audits. This position may function as a backup to the Facility Coordinator as needed and be responsible for various aspects of our facility, including liaison with the landlord, managing pest control/documentation of issues, administration of facility’s security system and the preventative maintenance programs associated with the roof, and various equipment. The incumbent will also deliver training programs and assume supervisory responsibilities on an as needed basis. Expected to apply their moderate understanding of current Good Manufacturing Practices (cGMP) experiences
along with strong critical thinking skills to handle responsibilities of a moderate complex nature within the Clinical Materials Services Unit (CMSU). Assists in developing and designing packaging equipment and materials for safe, convenient, and attractive transport of goods under various conditions. Reviews engineering drawings and specifications to determine the required type of packaging materials and to maximize convenience, utility, and function based on the product's physical characteristics, safety, and special handling requirements. Ensures compliance with safety and quality standards. Identifies packaging materials to eliminate damage or contamination of shipments.

ESSENTIAL FUNCTIONS

• Handling of drugs, devices and components in accordance with cGMPs during receipt, warehousing, processing, distribution, return and destruction.
• Manage emails associated with study team activations.
• Mange Pull and Ship (PNS) Box schedule and fulfillment of orders.
• Conduct line clearances and cleaning in conjunction with QA.
• Inspection of pre-labelled kitted/bottled product and organization, as applicable on pallets to ease Pull and ship process.
• Support execution of I/O/PQ and Production Validation Protocols for packaging equipment.
• Document Generation: Working independently at the direction of the functional manager, author draft versions of original and revised documents (Clinical Materials Specification Sheet (CMSS) and SOP’s) and lead the draft document through the review process until a finished version of the document is approved.
• With oversight from functional manager, generate draft version of Standard Operating Procedures (SOPs), Processing Order and Clinical Material Specification Sheet (CMSS) documents.  
• Working with some guidance ensure documents are tracked from draft stage through to final approval stage.
• Participate in Client team meetings, provide updates on CMSU deliverables and keep CMSU management apprised of study progress and need for additional project resources.  
• Support inspections by regulatory agencies and external auditors.   
• Participate in Client team meetings, provide updates on CMSU deliverables and keep CMSU management apprised of study progress