Manufacturing Associate - Quad ; Harvest

Position:
Manufacturing Associate

Duration: 06 Months

Location:

Summit West, NJ 07901

Schedule:

Open Harvest Aseptic Manufacturing - (Quad 1: Sunday-Tuesday, alt Wednesdays 5 am to 5:30 pm)

• The training period may range from 1 to 6 weeks, depending on business needs, as determined by the client.
• 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
• 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

• 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, ptic 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.

• 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.

• 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.

• 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.