Manufacturing Associate - Shift 1

Spectraforce Technologies, Inc.; Summit (NJ); On-site; USD 25,000 - 30,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Manufacturing Associate for a 6-month assignment in Summit, NJ. You will perform set-up and operation of cleanroom equipment to support production of blood component lots, following SOPs and GMP in a team-based environment.

You will participate in deviation investigations, assist with CAPAs, and maintain accurate production records. Training starts with 1–2 weeks at 9:00 AM–5:00 PM before transitioning to the quad shift.

Qualifications

• Bachelor's degree or equivalent in a related field.
• Experience with cell culture, aseptic technique, and cGMPs is required or preferred.
• Strong technical writing and documentation skills.
• Proficiency in MS Office applications and data recording.
• Background in biology, chemistry, medical or clinical practices preferred.
• Ability to work in a cleanroom environment and follow SOPs.
• Must be able to work in a team within a fast-paced production setting.

Responsibilities

• Set up and operate equipment to support production of blood component lots (cell culture, harvest, cryopreservation).
• Support deviation investigations and close CAPAs within the assigned shift.
• Maintain aseptic technique for tubing, connections, and transfers; aseptic qualification is required.
• Weigh and measure in-process materials to ensure correct quantities.
• Adhere to production schedule and internal production logistics.
• Record production data clearly according to GDPs.
• Perform tasks in alignment with site safety, quality systems, and GMP requirements.
• Work in a cross-functional team to complete shift schedule tasks.

Skills

Cell culture basics

Aseptic processing

cGMP knowledge

Technical writing

MS Office

Biology/chemistry background

Education

Bachelor's degree

Associate/Medical Technical degree + 3 years experience

High School diploma/GED + 2 years experience

Job description

Position: Manufacturing Associate

Duration: 06 Months

Location: Summit West, NJ, 07901

Shift 1 Tuesday-Saturday, 6:00am-2:30pm

Training schedule:

• 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.

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: Knowledge/ Skills, and Abilities

• 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

Duties and Responsibilities:

• 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, at minimum. Aseptic 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.

Education and Experience:

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.

Important Notes about working in the clean room:

• 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.

Working Conditions:

• 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.