Manufacturing Associate - 1st shift
1 day ago
Summit
Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Breyanzi activation MO QUAD SCHEDULE: Breyanzi MO Associate 1st shift, Tuesday through Saturday, from 6:00 am to 2:30 pm 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, • 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, • 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 is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required., • 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., • Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements., • 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., • Become a 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., • Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc. 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 which cover 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:, • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time 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 job environment., • Ability to lift 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.Exposure to strong magnets is likely., • Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.