Manufacturing Associate - Quad 4

Spectraforce Technologies; Summit (NJ); On-site; USD 42,000 - 52,000; Full time

Job summary

Spectraforce Technologies is seeking a Manufacturing Associate for a 6-month position in Summit, NJ. The role involves producing blood component lots in a cGMP cleanroom under supervision of Manufacturing Management, adhering to SOPs and GDPs, and communicating production deviations for quality investigations.

Required background includes biology/chemistry knowledge, basic lab technique, and MS Office proficiency.

Qualifications

• Bachelor’s degree or Associate/Medical Tech degree with 2 years of manufacturing or operations experience, or High School diploma/GED with 4 years of manufacturing or operations experience.

Responsibilities

• Produce blood component lots through cell culture, harvest, and cryopreservation.
• Aseptic techniques for all production activities; welding, connections, and transfers.
• Weighs and measures in‑process materials to ensure proper quantities.
• Adheres to production schedule to ensure on-time internal production logistics.
• Records production data in a clear, concise format per GDPs.
• Works in a cross‑functional team to complete shift tasks.
• Leads a team within a function; supervision by the shift Supervisor.
• No direct reports will be assigned to this job role.
• Performs other tasks as assigned.
• Gowning in GMP clean room up to 6 hours; PPE required.
• Lift up to 25 pounds and work around laboratories and restricted areas.

Skills

Cell culture basics

cGMP knowledge

Math skills

Technical writing

MS Office

Biology background

Education

Bachelor/Associate/Medical Tech

High School Diploma

Job description

Position

Manufacturing Associate

Duration

06 Months

Location

Summit West, NJ 07901

Shift Details

Quad 4 Thu-Sat, alt Wed 5pm-5:30am

Training Schedule

• 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.

Description

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.

Required Competencies

• 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 (Entry‑Level)

Duties and Responsibilities

• 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.

Education and Experience

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

Important Notes about working in the clean room

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.

Working Conditions

• 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.

Disclaimer

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.