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Quality Control Technician - Radiology

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Job Number: 80963
Category: Research & Laboratory
Location: 5323 Harry Hines Blvd, Dallas, TX
Department: 428028 - RA-Radiological Science
Full/Part Time/PRN: Day Job
Regular/Temporary: Regular
Schedule: Full-time

Security


This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information

Salary


Salary Negotiable

Experience and Education


Master's degree with major coursework in field of assignment and no experience required.

Bachelor's degree with major coursework in field of assignment and one (1) year research experience at level of Research Technician or equivalent.

Two (2) years college with emphasis in coursework in field of assignment and four (4) years research experience including two (2) years at level of Research Technician or equivalent.

High school graduation or GED and six (6) years research experience to include two (2) years at level of Research Technician or equivalent.

Job Duties


Performs more difficult scientific and medical research work in science area such as biology, chemistry, physics, or other related scientific field.

Constructs, assembles, and operates laboratory equipment and apparatus.

Records and evaluates data obtained from work assignments for use in scientific papers.

Collaborates with supervisor or other research personnel in preparation of scientific papers for publication.

Reads literature and confers with supervisor concerning procedures and implementation.

Collects and organizes research data for project reports.

May plan for, and provide working supervision to, work of Research Technicians or other laboratory personnel of lower grade.

Performs other duties as assigned.
Other Job Duties

Primary responsibilities of this position are to test and qualify PET drugs, along with the materials and supplies used in the production of PET drugs, and work as an assistant to the Regulatory Affairs Officer to assure the CRP operations are in full compliance with US FDA regulations (21 CFR Part 212) governing the production of PET drugs for human uses and the United States Pharmacopeia Chapter 832

Manage the quality control (QC) laboratory for preclinical and clinical uses of radiopharmaceutical
Develop QC methods for characterization and quantification of pharmaceutical products/impurities and writes/maintains corresponding standard operating procedures (SOPs)
Conduct performance qualifications along with calibrations and other equipment suitability testing to ensure the validity of analytical procedures/methodology in accordance with ICH (International Conference on Harmonization) and USP (The United States Pharmacopeial Convention) guidelines on radiopharmaceuticals
Perform maintenance and troubleshooting for QC analytical instruments (HPLC, FPLC, LC-MS, ICP-MS) by working with contracted vendors
Participate in CRPs general facility maintenance along with cleaning/sterilization of the current good manufacturing practice (CGMP) radiopharmacy lab
Prepare and document QC methods, data, release criteria of radiopharmaceuticals for regulatory filings and compliance
Manage facility raw materials from inventory tracking to ordering, receiving, and accepting according to US-FDAs CGMP lab guidelines
Preferred Qualifications

Experience with analytical methodologies (chemical and microbiological) in a similar environment for production of positron emission tomography (PET) drugs and quality management is desired.

UTSouthwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; sex; including sexual harassment; age; disability; genetic information; citizenship status; and protected veteran status. In addition, it is UTSouthwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.

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