CMSU Research Quality Assurance Coordinator III

University of Rochester•Wallingford, CT

16d•$25 - $35

About The Position

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. Possess an advanced 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 independently with minimal 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 will 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 advanced understanding of 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).

Requirements

Associate degree in appropriate discipline required.
3-5 years of specialized work experience, preferably in the pharmaceutical industry or clinical trial supply experience required.
Or an equivalent combination of education and experience required.
Strong working knowledge of GMPs along with computer skills (Word, Excel).
Excellent communication skills, including written communication.
Strong attention to detail, excellent time management, and organizational skills.
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.

Nice To Haves

Bachelor’s degree in appropriate discipline preferred.

Responsibilities

Processing Operations: To follow GMPs and high quality standards in the labeling of clinical materials according to written procedures. Must have thorough understanding of the relation of the required labeling to the overall study design. Provide feedback as to improvements in existing systems and procedures. Execution of I/O/PQ and Production Validation Protocols for packaging equipment. Provide quality, timely, consistent clinical trial drug and device packaging in strict compliance to Good Manufacturing Practices (GMPs). 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 Participate in the development of packaging equipment requirements, assessment of equipment capabilities and recommendations for purchase
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. Generate draft version of Standard Operating Procedures (SOPs), Processing Order and Clinical Material Specification Sheet (CMSS) documents. Upon final review, 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. Represent the CMSU at industry conference exhibits when needed. Participate directly in inspections by regulatory agencies and external auditors.
Document Management: Accurately execute and file all documentation generated in routine departmental operations. Constantly review the necessity and effectiveness of existing forms and recommend appropriate changes, additions and deletions. Generate, organize and maintain documents in compliance with requirements of cGMPs.
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. Help determine departmental needs and support the ordering all packaging components critical to the assembly of finished study drug/device kits/packages from approved vendors. Ensure electronic inventory system are appropriately maintained as orders are fulfilled. Support incoming inspection and inventory of cold change supplies at CMSU and any off-site warehouse. Support Annual Inventory of drug, devices and components. Maintain a GMP compliant system for the return and accounting of all returned investigational products.
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. Follow-up with clinical trial sites in response to inquiries and resolve problems.
Facility and Equipment maintenance: Support metrology of clinical materials support equipment.
Facility Operations: Organize and maintain a GMP compliant facility. Duties include shipping, receiving and accurate record keeping. Organize and maintain a GMP compliant storage and processing area within the CMSU facility. Organize and maintain a GMP compliant storage facility. Ensure warehouse and GMP areas are maintained and cleaned per required SOPs schedule. Assist with temperature mapping and monitoring of the warehouse and freezers/refrigerators Assist the Director, with administration of the facility’s access system. When necessary, liaise with UR ISD to resolve IT and phone system issues.
Development and Delivery of Training Programs: At the direction of the functional manager develop the training program and associated documentation to support new processes, projects and training modules. Develop Training Program. Delivery of Training Programs to CMSU/CTCC/CHET personnel.
Assume interim supervisory responsibility: At the designation or absence of the functional manager, assume short-term responsibility for specific aspects of day-to-day operations.
Participate directly in inspections by regulatory agencies and external auditors: With oversight of the functional manager provide support for regulatory inspections and external audits, and when needed interact directly with regulatory agency representatives and other auditors.
Other job duties and projects as assigned.