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Cleanroom Associate/ Cell Processing Tech/ Manufacturing Technician/ Cell Culture Associate at Spectraforce Technologies Inc

Cleanroom Associate/ Cell Processing Tech/ Manufacturing Technician/ Cell Culture Associate

Spectraforce Technologies Inc Summit, NJ, NJ
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Job Title: Cleanroom Associate/ Cell Processing Tech/ Manufacturing Technician/ Cell Culture Associate

Job Location: Summit, NJ 07901

Duration: 6 Months (Temp to Perm)

Note: Recent grads are encouraged to apply

Shifts: Night Shifts

Quad 2 - 5 pm to 5:30 - Sunday through Wednesday

Quad 4 - 5 pm to 5:30 - Wednesday through Saturday

Purpose and Scope of Position

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. Day shift structures are Quad 1 or Quad 3, 5 am-5:30 pm, Sunday through Wednesday or Wednesday through Saturday. Night shift structures are Quad 2 or Quad 4, 5 pm to 5:30 am, Sunday through Wednesday or Wednesday through Saturday. Start and end times are subject to change based on business demands.

Required Competencies: Knowledge/ Skills, and Abilities:

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

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 experienceor High School diploma/GED and 2 years of Manufacturing or Operations experience.

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.

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.

Recommended skills

Biology
Cell Culture
Chemical Engineering
Gmp
Media Preparation
Pharma Manufacturing
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