Job Location: Summit, NJ 07901
Duration: 6 Months (Temp to Perm)
Note: Recent grads are encouraged to apply
Shifts: Night Shifts
Quad 2 - 5 pm to 5:30 - Sunday through Wednesday
Quad 4 - 5 pm to 5:30 - Wednesday through Saturday
Purpose and Scope of Position
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. Day shift structures are Quad 1 or Quad 3, 5 am-5:30 pm, Sunday through Wednesday or Wednesday through Saturday. Night shift structures are Quad 2 or Quad 4, 5 pm to 5:30 am, Sunday through Wednesday or Wednesday through Saturday. Start and end times are subject to change based on business demands.
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
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.
Education and Experience:
Bachelor’s degree or Associate/ Medical Technical degree and 3 years of Manufacturing or Operations experienceor High School diploma/GED and 2 years of Manufacturing or Operations experience.
● 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.