Manufacturing Associate - Quad ; Closed Ops

Position:
Manufacturing Associate

Duration: 06 Months

Location: Summit West, NJ, 07901

Shift

Schedule:

Closed Ops Manufacturing (Q4 Wednesday to Saturday alternating Wednesday off 5pm to 530am)

• Training period may range from 1 to 6 weeks, depending on business needs.
• Selected candidate must maintain full availability, with no planned leave during the entire training period.
• Training will commence Monday to Friday, 9:00 AM – 5:00 PM for the initial 1-2 weeks (subject to change based on business needs).
• 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. Duties are performed within a team according to an assigned production shift schedule. Communication of production deviations and assistance with quality investigations is required, as applicable.

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of relevant topics (details omitted in original).
• Basic mathematical skills.
• 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 on time closure of any assigned CAPAs within the designated shift.
• Aseptic technique required for 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 concisely 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 needed to fulfill job requirements.
• Become an 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.
• Perform 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.
• 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; may be required to sit or stand for extended periods.
• Comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability.
• Ability to lift 25 pounds.
• Exposure to human blood components, sanitization agents, and strong magnets expected.
• Cleanroom environment is an enclosed, restricted space with assigned pressure and temperature conditions.
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, etc.