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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 and need for additional project resources.

+ Support 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 routine maintenance of freezers/refrigerators.

+ 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.

+ Delivery of Training Programs to CMSU/CTCC/CHET personnel.

+ Development of Training Programs

+ 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.

QUALIFICATIONS

+ Associate degree in appropriate discipline required

+ Bachelor’s degree in appropriate discipline preferred.

+ 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.

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Classes). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates for all persons consistent with our values and based on applicable law.

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Learn. Discover. Heal. Create.

Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.

If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals

At the University of Rochester, we commit to diversity, equity, and inclusion and united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.