Laboratory Technician

Company: SOFIE
Location: Totowa
Posted on: April 9, 2025

Job Description:

Title Laboratory Technician

A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.

Location NJ5-Totowa, New Jersey

Department Radiopharmaceutical Contract Manufacturing

Training Curriculum ID TCU.004

Overview: The Laboratory Technician supports the QC and Microbiology departments at the NJ5 site by (1) preparing and maintaining reagents and other supplies in the QC Laboratory, disposing of used supplies, and performing simple instrument calibration and maintenance, and (2) performing Environmental Monitoring (EM) and by preparing/maintaining EM supplies and disposing of used EM supplies.

Essential Duties and Responsibilities

--- Prepare standards, samples, and mobile phase solutions for analytical methods.

--- Perform simple calibration and maintenance of QC and microbiology laboratory equipment on site.

--- Dispose of QC and microbiology waste (common, biologic, hazardous, and radioactive) in accordance with instructions and regulatory requirements.

--- Perform routine housekeeping and cleaning in the QC and microbiology laboratories. Operate lab glassware washer and manage glassware within the labs.

--- Assist with EM sampling in accordance with schedules, and procedures, performing sampling of rooms and equipment.

--- Assist with sampling, handling, and shipping of QC and microbiology samples for external testing, including raw material, finished product and environmental isolate samples.

--- Assist with non-complex Quality Control analytical tests, under supervision of chemists, for regular production of radiopharmaceuticals for preclinical, clinical, or commercial use according to cGMP standards.

--- Comply to all applicable standard operating procedures and regulations, including 21 CFR Part 211 and Eudralex Volume 4 requirements.

--- Maintain all qualification and validation requirements for entering ISO classified areas.

--- Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.

--- Other duties as assigned.

Qualifications

--- Minimum Associate Degree in a Life Science discipline (in chemistry, biology/ microbiology, or related field preferred) and 0-3 years in a cGMP laboratory/ production environment including supporting QC and/or microbiology services.

--- Knowledge of and previous experience performing Environmental Monitoring is preferred.

--- Knowledge of USP, FDA, and cGMP regulations preferred.

--- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.

--- Ability to define and solve problems, collect data, establish facts, and draw valid conclusions required.

--- Proficiency in MS Office applications required.

--- Strong interpersonal communication skills for interacting with site personnel in both quality and manufacturing.

Keywords: SOFIE, Bethlehem , Laboratory Technician, Professions , Totowa, Pennsylvania