Manufacturing Associate - Quad 4
18 hours ago
Summit
Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Breyanzi activation MO QUAD SCHEDULE: Quad 4 Alternating Wed & Thurs-Sat 5 pm - 5:30 am Training schedule: 4-6 weeks, ONSITE training (9 - 5, Mon - Fri) Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned., • Education and Experience: Bachelor's degree or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components.