Job Description

Work Schedule

Rotational shift days

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Operator


Summary of Function:


Efficient, timely, and GMP-compliant preparation, execution, and completion of manufacturing and packaging orders, including the performance of in-process controls (IPCs), as well as the cleaning of equipment and machine parts.


Your Responsibilities:


o Efficient, timely, and GMP-compliant preparation, execution, and completion of manufacturing and packaging orders, including the performance of in-process controls (IPCs) o Efficient and GMP-compliant cleaning of equipment and machine parts, as well as production areas o GMP-compliant documentation of all performed activities o Compliance with specific regulations for the manufacturing and packaging of clinical trial samples, in particular GMP rules, hygiene and safety regulations, and all relevant Standard Operating Procedures (SOPs) and work instructions o Ensuring active, timely, and appropriate communication of progress and challenges to colleagues and supervisors o Active participation in identifying, communicating, and resolving problems and inefficiencies, as well as contributing to improvement opportunities o Working in temperature-controlled (cold) areas