"Alerted.org

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 109 H

Compensation Range:

$26.90 - $37.66

_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

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 Quality Assurance function of Clinical Materials Services Unit (CMSU).

ESSENTIAL FUNCTIONS

Quality Assurance Review and Verification of Production Operations

+ Oversees production receiving of incoming materials, warehouse storage and inventory maintenance.

+ With Production personnel, conducts line cleaning/clearance of packaging/labeling operations, provides final shipping inspection of CMSU finished goods and oversees receipt and destruction of rejected and returned material.

+ Conduct line clearance / cleanliness verifications prior to production of finishing /assembly operations.

+ Conduct routine sampling, inspection and testing of clinical products and packaging components to pre-approved specifications.

+ Incoming inspection and review of all labeling, drug products and components documentation for conformance to pre-approved specifications.

Incoming Inspection of Materials

+ Uses statistically based sampling plans to perform quality inspection of attributes for drug products, packaging and labeling components and assembled clinical supplies.

+ In compliance with internal Standard Operating Procedures, execution of documentation policies and procedures for production record control including distribution records and maintenance of filing systems.

+ 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.

+ Provide QA support to software set-up / model verification in the utilization of ClinPro LBL ™ computerized clinical label generation system.

Systems Support

+ Provides routine QA verification of proper model generation of ClinPro LBL ™ label generation system, supports ClinPro by acting as second QA check of the execution of validation scripts, and manages metrology activities; calibration of in-process packaging equipment and environmental monitoring equipment.

Internal Compliance Review (Internal Audits)

+ Conducts internal audits, retrospectively, of project records, facility management and SOP’s to establish the level of compliance to internal policies and procedures, project requirements.

+ Audit findings are reported to the respective functional manager for responses and corrective actions.

+ Conduct internal compliance audits of CMSU operations, in accordance with internal procedures, and report findings to CMSU management.

+ Participate in adoption of Corrective and Preventative Action (CAPA) plans.

+ Writing and periodic review of internal Standard Operating Procedures.

Technical Writing

+ Write new and update existing SOP’s as needed. Author validation protocols as necessary for new and existing equipment.

+ Set-up QA metrology activities and maintain control for calibration/validation/distribution and documentation of all equipment as applicable.

+ Provide input into validation protocols and implement computer system validation of computerized clinical labeling hardware and software.

+ Writing of validation protocols that support CMSU infrastructure and equipment.

Training

+ Conducts and documents training of other QA technicians on QA processes and procedures that support the QA function within CMSU.

+ Conduct training of other QA technicians that support the QA function within CMSU.

QA Liaison to External Entities

+ Participate in problem investigations (product complaints) from external, investigational sites.

+ Work with clients on certain aspects of project related issues.

+ Conduct and document follow-up investigations as needed to resolve quality related issues.

+ Assist in and participate in problem investigations both internally and at investigational sites

+ Act as the QA liaison to external client inquiries regarding project related issues.

+ Follow-up with clinical trial sites in response to inquiries and resolve problems.

Other job duties and projects as assigned.

MINIMUM EDUCATION & EXPERIENCE

+ Associate’s degree in appropriate discipline. Required

+ Bachelor’s degree in appropriate discipline.Preferred

+ 4 years of specialized work experience, preferably in the pharmaceutical industry and/or clinical trial supply experience. Required

+ Or equivalent combination of education and experience. Required

KNOWLEDGE, SKILLS AND ABILITIES

+ 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 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.

Notice: If you are a **Current** **Employee,** please **log into myURHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.

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.