Research Qual Assurance Spec I

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 PURPOSE
Possess an extensive 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 act independently in the areas of review and approval of critical documents; SOP’s, Process Orders and CMSS documents. The QA Lead will be responsible for the execution of IQ/OQ/PQ validations of CMSU equipment and temperature mapping/monitoring of CMSU cold room, warehouse, processing rooms, refrigerators and freezers. Additionally, participate more directly in regulatory and client audits as well as represent CMSU at business development functions and engaging with new and existing clients.

Apply their extensive understanding of 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).

This position is responsible for document management within the secure CMSU Document Room including proper filing, document release, tracking and management. As a team lead, will also support and allocate resources to support these activities.

ESSENTIAL FUNCTIONS

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. 

• Incoming inspection and review of all labeling, drug products and components documentation for conformance to pre-approved specifications.
• Conduct routine sampling, inspection and testing of clinical products and packaging components to pre-approved specifications.

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.
• 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.
• Inspection of pre-labelled kitted/bottled product and organization, as applicable on pallets to ease of Pull and ship process.
• Supports Oversees receiving of incoming materials, warehouse storage and inventory maintenance by:
• The review and approval of all documentation associated with standard pull and ship operations (PNS) required to ship labeled product to site for use by clinical trial participants. This includes the first QA check only.

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. 

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 environmenta