Manufacturing Associate - Quad 4 (Closed Ops)

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Shift Schedule: Closed Ops Manufacturing (Q4 Wednesday to Saturday alternating Wednesday off 5pm to 530am) Training Schedule Training period may range from 1 to 6 weeks, depending on business needs. Selected candidate must maintain full availability, with no planned leave during the entire training period. Training will commence Monday to Friday, 9:00 AM – 5:00 PM for the initial 1-2 weeks (subject to change based on business needs). Schedule will transition to the assigned Quad shift. 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. Duties are performed within a team according to an assigned production shift schedule. Communication of production deviations and assistance with quality investigations is required, as applicable. Required Competencies Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. Knowledge of relevant topics (details omitted in original). Basic mathematical skills. General understanding of cGMPs. Technical writing capability. Proficiency in MS Office applications. Background in 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 on time closure of any assigned CAPAs within the designated shift. Aseptic technique required for most activities: welding, connections, and transfers, at minimum. Aseptic qualification 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 concisely 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. Additional Responsibilities Motivated, team‑conscious individuals needed to fulfill job requirements. Become an SME and qualified trainer within a designated function of manufacturing; supervision will be managed by the shift Supervisor or designated Team Lead. Maintain on‑time completion of training assignments to maintain the 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 and 3 years of Manufacturing or Operations experience. or High School diploma/GED and 2 years of Manufacturing or Operations experience. Important Notes about working in the clean room Must have the ability to work around laboratories and controlled, enclosed, restricted areas. Ability to wear cleanroom garments and personal protective equipment (gloves, frocks, and hoods) required in designated areas. 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 Intermittent walking and sitting to perform job functions; may be required to sit or stand for extended periods. Comfortable working with contained human blood components. Physical dexterity sufficient to use computers and documentation. Sufficient vision and hearing capability. Ability to lift 25 pounds. Exposure to human blood components, sanitization agents, and strong magnets expected. Cleanroom environment is an enclosed, restricted space with assigned pressure and temperature conditions. Designated areas may prohibit food, any outside materials such as cell phones, tablets, etc. #J-18808-Ljbffr Spectraforce Technologies