CMSU Facility Coord / GMP Operations Tech IV - University of Rochester

GENERAL PURPOSE: The CMSU Facility Coord / GMP Operations Tech IV is responsible for ensuring that clinical trial supplies are on site for use by clinical trial participants, and that they are properly and safely stored, and temperature controlled as required. Secondary responsibility is to support the Clinical Research Packaging department. As the CMSU factility must be GMP compliant at all times, there may be times that facility responsibilities take priority over packaging activity to ensure CMSU is still able to meet its overall mission of having GMP Clinical supplies on site at the time they are required by clinical trial participants. **Environmental Monitoring** **:** will be responsible for coordinating all activities related to maintenance of the CMSU Facilities and equipment to ensure full compliance with all NYS, Federal and ICH regulations associated with current Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs), and other regulatory agencies. **Clinical Research Packaging support** **:** The incumbent in this 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 for the level IV position + Under supervision of assigned management, coordinate to ensure that CMSU facilities are in compliance with cGMPs. This includes but is not limited to: + Management of appropriate temperature controls in the warehouse, freezers/referigerators and cold room + Coordinate temperature mapping, as needed of warehouse, freezers/refigerators and cold room per CMSU SOPs and maintain applicable documentation. + Overall warehouse management – organization of pallets in racking system, receipt/quarantine/inventorying of incoming materials in conjuction with other operations staff and release by QA + Coordinate generator maintenance, repair, load testing etc. and documentation per CMSU SOPs. + Coordinate the Pest control plan with URMC Enviormental Controls per CMSU SOPs and ensure proper documentation + Ensure CMSU perimenter checks, including external storage units are completed as per CMSU SOPs and appropriately documented. + Ensure external storage units are properly maintained and coordinate repairs as applicable with applicable documenation + Ensure integrity of the overall facility including: outside walls, roof, parking lot, lighting, loading dock, including air curtain, lawn care etc. by contacting the building landlord in case any issues were identified that required repair by the landlord. + Responsible for ensuring that any repairs required inside CMSU space are appropriately fixed by the applicable contractors + Ensure HVAC system is working properly and geneator backup to the warehouse is tested per CMSU SOPs and all maintenance, repairs, service calls etc. are appropriately documented. + Ensure service provider for housekeeping contract is in place and housekeeping activities are being performed as appropriate + Ensure annual CMSU annual cleaning is scheduled and completed per CMSU SOPs + Manage all CMSU external facilty vendors and providors to ensure applicable work is completed, invoices are submitted for payment with applicable breakdown by project as applicable. + Manage and ensure CMSU security system and hardware are appropriately functioning, if applicable. Service and repairs are appropriately updated per CMSU SOPs. Under supervision of assigned management ensure that CMSU equipment are in compliance with cGMPs. This includes but it not limited to: + Freezers/refrigerator and cold room are calibrated and defrosted per CMSU SOPs with appropriate documentation + Fork lift, Tow mows etc. are maintained and repaired per equipment requirements and CMSU SOPs and documented appropriately + Temperature monitoring tags are maintained, repaired and replaced per CMSU SOPs and appropriately documented. + Maintain Fire/life Safety (ADM)/Safety (Safety Harness for lift Cage and tow mow) equipment and appropriate documentation + Research and recommend any new equipment that CMSU may need to the appropriate Director for applicable approvals Obtain applicable training in all areas of facility and equipment responsibilities to stay current with GMPs. In the event that new space is acquired/built out, would actively particiapate inall aspects of converting the space to cGMP compliant space as needed, including air handling systems, water, utilities, backup generators, security, etc. The buildout would be managed by the assigned URMC Real Estate Project Manager. Other duties would be adjusted if a buildout were to move forward. **Clinical Research Packaging Technician 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. **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. 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. **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. **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. **Delivery of Project Specific Training:** Deliver training to CMSU personnel involving existing processes, projects and training modules. **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 Execution of IQ/OQ/PQ and Production Validation Protocols for packaging equipment. This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required. **QUALIFICATIONS:** + High School diploma required + Some college desirable, science related bachelor’s degree preferred + Minimum 2 years of pharmaceutical industry experience and/or clinical trial supply experience, + or equivalent combination of education and experience required + Strong working knowledge of GMPs, GMP facility requirements required + Strong computer skills (Word, Excel) required + Excellent oral and written communication skills required. + 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 required. The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations. **Location:** School of Medicine & Dentistry **Full/Part Time:** Full-Time **Opening:** Full Time 40 hours Grade 079 Neuro-Ctr Human Exp Ther/CMSU **Schedule:** 8 AM-5 PM; OCC WKNDS