Manufacturing Associate - Quad

Position:
Manufacturing Associate

Duration: 06 Months

Location:
Summit West, NJ 07901

• Training period may range from 1 to 6 weeks, depending on business needs, as determined by the client.
• Selected candidate must maintain full availability with no planned leave during training.
• Training commences Monday‑Friday, 9:00 AM – 5:00 PM for the initial 1‑2 weeks (subject to change).
• Schedule then transitions to the assigned quad shift.

Manufactures human blood‑derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under manufacturing management. Manufacturing associates adhere to regulatory requirements while performing job functions. 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 mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background including knowledge 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 timely closure of any assigned CAPAs within the shift.
• Use aseptic technique for most activities: welding, connections, and transfers; aseptic qualification is 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 the shift schedule.
• Motivated, team‑conscious individuals are needed to fulfill job requirements.
• Become an SME and qualified trainer within a designated manufacturing function; supervision managed by the shift supervisor or team lead.
• Maintain on‑time completion of training assignments to maintain necessary technical skills and process knowledge.
• Perform other tasks as assigned: continuous improvement projects, inspection readiness, right‑first‑time initiatives, etc.

Bachelor's degree. Or Associate/Medical Technical degree with 3 years of manufacturing or operations experience. Or High School diploma/GED with 2 years of manufacturing or operations experience.

• Must be able to work around laboratories and controlled, enclosed, restricted areas.
• Must wear cleanroom garments and personal protective equipment (gloves, frocks, hoods) required in designated areas covering 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.

This position takes place in a GMP cleanroom environment, which includes being gowned for up to 6 hours. During processing time in the clean room, no breaks may be taken.

• Intermittent walking and sitting to perform job functions; ability to sit or stand for extended periods 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 the environment.
• Ability to lift 25 pounds.
• Must work around laboratories and controlled, enclosed, restricted areas.
• Must use cleanroom garments and PPE required in designated areas covering head, face, core body, and legs/feet.
• Prohibited items: makeup, gum, nail polish, or other potential microbial sources.
• Flexibility to don cleanroom garments and PPE.
• Cleanroom is an enclosed, restricted space with assigned pressure and temperature; reagents, chemicals, and sanitization agents are expected.
• Routine exposure to human blood components. Exposure to strong magnets is likely.
• Designated areas may prohibit food, and outside materials such as cell phones, tablets, etc.