Quality Control Technician

Job Title:

Quality Control TechnicianFLSA Status:

Non-ExemptPosition Type:

Full TimePay Type:

Salary - HourlyPharmaLogic is the fastest-growing

SPECT & PET

radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

Role Summary:

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.

Job Responsibilities and Duties:

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.

Job Requirements Skills Education:

Requires a bachelors 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. 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. 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%.

Physical and Intellectual Requirements:

Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and to handle frequent crawling, stooping, crouching and kneeling; ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

Benefits Include:

401(k) retirement benefit program Medical Dental care Disability insurance Employee assistance program Extended health care Life insurance On-site parking Paid time off Vision care 8 am to 4 pm or 9 am to 5 pm40/week