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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 108 H

Compensation Range:

$24.91 - $34.87

_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 PURPOSE:

Assists in the development and design of packaging equipment and materials for safe, convenient and attractive transport of goods under a variety of conditions. Analyzes 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. Evaluates packaging and transporting methods and procedures to ensure compliance with safety and quality standards. Evaluates and recommends efficient packing procedures, innovations in packaging materials, and utilization of sealing and fastening devices. Identifies packaging materials to eliminate damage or contamination of shipments. Analyzes and develops design options for structure, systems, and components. Determines manpower and cost estimates for packaging procedures. Evaluates packaging and transporting methods and procedures.

ESSENTIAL FUNCTIONS

+ 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.

MINIMUM EDUCATION & EXPERIENCE

+ Associate's degree and 3 years of relevant experience, preferably in the pharmaceutical industry or clinical trial supply required

+ Bachelor's degree preferred

+ Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

+ Strong working knowledge of GMPs along with computer skills (Word, Excel) required

+ Excellent communication skills, including written communication required

+ Strong attention to detail, excellent time management, and organizational skills required

+ Ability to work well in a team environment required

EOE Minorities / Females / Protected Veterans / Disabled:

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.

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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.