Quality Control Technician

PHARMALOGIC HOLDINGS•Idaho Falls, ID

7h•Onsite

About The Position

As a QC Technician, you will play an essential role in the development, implementation, and validation for new radiopharmaceuticals, radiochemical and isotope production. The position will have hands-on experience with radiochemistry synthesis, purification, and formulation for imaging and biodistribution studies; executing studies in parallel; and working alongside other laboratory scientists.

Requirements

Requires a bachelor’s degree in chemistry, Radiology, Nuclear Medicine, Nuclear Physics, Nuclear Engineering or related fields.
3-5 years of working in a GMP manufacturing environment and with FDA cGMP regulations required.
Superior teamwork, multi-tasking, and time/project management skills.
Excellent communication, analytical, problem solving, presentation and computer/PC skills (including proficiency in Microsoft Suite and related software).
Ability to work varying shifts and travel up to 10%.

Nice To Haves

Experience with laboratory procedures and radiochemistry techniques (separation techniques – SPE) and analytical method, equipment (ICP-MS, ICP- OES, GC, TLC, and radiometric measures) highly favored.
Experience with HPLC, radiochemistry synthesis, US FDA cGMP, Radiation Safety Principles, Isotopes production and analytical equipment troubleshooting and maintenance a plus.

Responsibilities

Responsible for production of radiotracers: Synthesis of generic and novel radiopharmaceuticals.
Purification of small and large molecules.
Maintain involvement with training and transfer of methods to and from QC and contract manufacturers as assigned.
Adapt, operate and maintain analytical instrumentation to produce accurate results.
Operate and maintain automated radiochemistry synthesis units.
Maintain experience with broad range isotopes and labeling methods and increase personal scientific, regulatory and compendial expertise.
Work with appropriate personnel to support, install, and qualify equipment on-site.
Assist with continuous improvement of current cGMP and non-GMP processes.
Follow all SOP guidelines for QC release testing of radiopharmaceutical products, raw material, finished and semi-finished products, environment, and facilities.
Modify and validate analytical procedures to meet QC needs.
Prepare chemical reagents for manufacturing and QC needs.
Maintain clean and safe work environment, performing radiation safety duties in compliance with safety and pharmaceutical regulations. Always demonstrate good safety practices including the appropriate use of protective equipment.
Support design and development of experimental protocols and procedures consistent with cGMP and cGLP.
Assist in QC stability testing, prepare and maintain stability records and summaries.
Perform other job-related duties as assigned.