Job Description

University of Utah Job Description

Job Summary

Under minimal supervision, responsible for planning, organizing, directing and controlling all aspects of the assigned department's internal and external Regulatory and Compliance activities as well as staffing and financial management operations as applicable. Acts as a catalyst between QA/QC team and other CTRM staff to ensure compliance and quality of service. 

Assists lab director in developing translational research protocols and Standard Operating Procedures that are in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP) regulation.

Qualifications

Bachelor’s degree in a scientific discipline and five years’ related experience required. Thorough knowledge of GLP/GTP and GMP regulations required. Demonstrated human relation and effective communications skills.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Essential Functions

1. Responsible for the creation, review, and implementation of SOPs, worksheets, forms, labels, and training documents
2. Ensures all controlled documents are in compliance with the requirements set forth by FDA, CAP, FACT, and AATB, as applicable
3. Oversees the physical facility to ensure CRF continues without interruption
4. Design, implement, performs and/or delegates QA audits
5. Supervises and coordinates QA/QC staff

Comments

Work Environment and Level of Frequency typically required

Nearly Continuously: Office environment.

Often: Infectious diseases

Seldom: Outdoor environment, extreme cold, extreme heat, noise, vibration, hazards, atmospheric conditions

 Physical Requirements and Level of Frequency that may be required

 Nearly Continuously: Sitting, hearing, listening

Often: Talking, repetitive hand motion (such as typing), walking

Seldom: Bending, twisting, climbing, kneeling, squatting, crawling, balancing, reaching overhead, pulling, pushing, lifting up to and over 50 lbs