Manufacturing Associate - Shift ; Closed Ops

Position:
Manufacturing Associate

Duration: 06 Months

Location:
Summit West, NJ 07901

• The training period may range from 1 to 6 weeks, depending on business needs
• The selected candidate is required to maintain full availability, with no planned leave during the entire training period.
• Training will commence with a Monday to Friday, 9:00 AM - 5:00 PM schedule for the initial 1-2 weeks (subject to change based on business needs).
• Subsequently, the schedule will transition to the assigned Quad shift.

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.

• 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

• 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.

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

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

• 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.
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job related duties as requested by management.