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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 116

Compensation Range:

$108,483.00 - $162,725.00

_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

Provides technical support to the quality and quality engineering (QE) functions. Conducts nondestructive examination (NDE) and quality control (QC) inspections on products, materials, components, parts, etc., at various stages of the production process to ensure compliance with established quality and reliability standards. Captures and analyzes statistical data from processes to either confirm compliance with established standards or identify deviations from standards. Recommends new or enhanced methods, procedures and standards. Has accountability for the performance and results of team, including hiring, performance reviews, and other personnel actions. Adapts departmental plans and priorities to address resource and operational challenges. Provides technical guidance to employees, colleagues and/or customers.

ESSENTIAL FUNCTIONS

+ Directs the activities of the Quality Assurance Compliance group within the Clinical Materials Services Unit (CMSU).

+ Oversees all aspects of Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices associated with CMSU’s compliance with State, Federal, and other regulatory authorities.

+ Responsible for the hiring and professional development of staff.

+ Oversees, develops, and coordinates the delivery of appropriate training for department personnel.

+ Provides compliance consulting and technical guidance to employees, colleagues, and/or customers.

+ Provides compliance support for the release of clinical trial supplies to allow for timely distribution in accordance with the international standards/regulations and client requirements.

+ Conducts batch and production record reviews, as necessary, and liaises with external vendors to ensure compliance with project and regulatory standards.

+ Responsible for administration of all internal Quality Assurance (QA) systems, including investigational drug and device procedures and processes.

+ Acts as an input and approval authority for all department operating policies and standard operating procedures to ensure federal and international regulatory standards are met.

+ Ensures all facilities and equipment remain in full compliance with State, Federal, and other regulations associated with applicable regulatory agencies.

+ Manages, directs, and oversees policies and procedures governing the storage and security of department documentation systems. Implements, directs, and oversees stability and expiry/retest program for all on-going studies. Interacts directly with client, Project Manager, Principal Investigators, and analytical facility to obtain needed reports, extend, and terminate stability protocols as dictated by each project.

+ Ensures that all QA requirements are met for projects.

+ Responsible for the identification, budget/contract negotiation, implementation, validation, and user acceptance testing of all technology, including inventory management system.

+ Ensures all staff are trained on new technology at time of implementation and as new hires come on board.

+ Research industry trends to identify additional technology from which the department would benefit.

+ Obtains proposals, vets vendors, and develops annual technology budget for new purchase and for routine maintenance of existing technology.

+ Acts as a consultant to all clinical research personnel on matters of international regulatory standards to maintain internal and regulatory compliance.

+ Participates in external and internal inspections from client companies and international regulatory authorities.

+ Manages, directs, and oversees vendor certification and qualification programs and Internal Quality Audit Program.

Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

+ Bachelor's degree and 3 years of relevant experience required

+ Or equivalent combination of education and experience

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 Characteristics). 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 are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are 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.