Manufacturing Associate - Quad

Position:
Manufacturing Associate

Duration: 06 Months

Location: Summit West, NJ, 07901

Shift: 5AM – 5:30 PM Sun – Tue / alternating Wednesday

Training

Schedule:

• Training period may range from 1 to 6 weeks, depending on business needs.
• Candidate must maintain full availability, with no planned leave during the training period.
• Initial 1–2 weeks:
  Monday–Friday, 9:00 AM–5:00 PM (subject to change).
• Subsequent periods: 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.
• Basic knowledge of mathematics.
• General understanding of cGMPs.
• Technical writing capability.
• Proficiency in MS Office applications.
• Background in 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 close of any assigned CAPAs within the shift.
• Aseptic technique required for tube most activities: welding, connections, and transfers, ptic 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 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.
• Work in a team‑based, cross‑functional environment to complete production tasks required by shift schedule.
• Motivated, team‑conscious 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 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 work around laboratories and controlled, enclosed, restricted areas.
• Ability to wear cleanroom garments and personal protective equipment (gloves, frocks, hoods) required in designated areas covering head, face, core body, hands, and legs/feet.
• Work in a manner that maintains cleanroom behaviors.
• Jewelry, makeup, hair products, nail polish, nail extensions or other potential microbial sources are prohibited in cleanroom work areas.

• Position in GMP clean room environment; gowned for up to 6 hours. No breaks may be taken during processing.
• Intermittent walking and sitting to perform job functions; must be able to sit or stand for extended periods.
• Comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Vision and hearing sufficient to work in job environment.
• Ability to lift 25 pounds.
• Exposure to reagents, chemicals, and sanitization agents expected.
• Exposure to strong magnets likely.
• Designated areas may prohibit food, outside materials such as cell phones and tablets.