Manufacturing Associate - Quad 3

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ 07901 Training Schedule Training period may range from 1 to 6 weeks, depending on business needs, as determined by the client. Selected candidate must maintain full availability with no planned leave during training. Training commences Monday‑Friday, 9:00 AM – 5:00 PM for the initial 1‑2 weeks (subject to change). Schedule then transitions to the assigned quad shift. Manufactures human blood‑derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under manufacturing management. Manufacturing associates adhere to regulatory requirements while performing job functions. 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. Basic mathematical skills. General understanding of cGMPs. Technical writing capability. Proficient in MS Office applications. Background including knowledge of biology, chemistry, medical or clinical practices. Duties and Responsibilities Perform set‑up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation. Support deviation investigations and write‑ups as needed. Support timely closure of any assigned CAPAs within the shift. Use aseptic technique for most activities: welding, connections, and transfers; aseptic qualification is required. Weigh and measure in‑process materials to ensure proper quantities are added/removed. Adhere to the production schedule ensuring on‑time, internal production logistics. Record production data and information in a clear, concise format according to proper GDPs. Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. Work in a team‑based, cross‑functional environment to complete production tasks required by the shift schedule. Motivated, team‑conscious individuals are needed to fulfill job requirements. Become an SME and qualified trainer within a designated manufacturing function; supervision managed by the shift supervisor or team lead. Maintain on‑time completion of training assignments to maintain necessary technical skills and process knowledge. Perform other tasks as assigned: continuous improvement projects, inspection readiness, right‑first‑time initiatives, etc. Education and Experience Bachelor's degree. Or Associate/Medical Technical degree with 3 years of manufacturing or operations experience. Or High School diploma/GED with 2 years of manufacturing or operations experience. Important Notes About Working in the Clean Room Must be able to work around laboratories and controlled, enclosed, restricted areas. Must wear cleanroom garments and personal protective equipment (gloves, frocks, hoods) required in designated areas covering the head, parts of the face, core body, hands, and legs/feet. Work in a manner to maintain cleanroom behaviors. Jewelry, makeup, hair products, nail polish, nail extensions or other potential microbial sources are prohibited in cleanroom work areas. Working Conditions This position takes place in a GMP cleanroom environment, which includes being gowned for up to 6 hours. During processing time in the clean room, no breaks may be taken. Intermittent walking and sitting to perform job functions; ability to sit or stand for extended periods may be necessary. Must be comfortable working with contained human blood components. Physical dexterity sufficient to use computers and documentation. Sufficient vision and hearing capability to work in the environment. Ability to lift 25 pounds. Must work around laboratories and controlled, enclosed, restricted areas. Must use cleanroom garments and PPE required in designated areas covering head, face, core body, and legs/feet. Prohibited items: makeup, gum, nail polish, or other potential microbial sources. Flexibility to don cleanroom garments and PPE. Cleanroom is an enclosed, restricted space with assigned pressure and temperature; reagents, chemicals, and sanitization agents are expected. Routine exposure to human blood components. Exposure to strong magnets is likely. Designated areas may prohibit food, and outside materials such as cell phones, tablets, etc. #J-18808-Ljbffr Spectraforce Technologies