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Manufacturing Associate

  • Location: Massachusetts
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 22 January 2022

​​​​​​​​​​​​​​​​​​​​Job Description:

  • Shift Times: M-F 8:00-4:00 pm. Schedule may change

Education:

  • High school diploma

  • 0-2 years of experience in cGMP biologics cell culture manufacturing is preferred

  • Bachelors in relevant science or engineering discipline is preferred Experience

  • Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations

  • Must be able to work in a cleanroom environment and perform aseptic processing

  • Must be comfortable being exposed to human blood components.

  • Must be able to be in close proximity to strong magnets.

Preferred Qualifications:

  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.

Duties And Responsibilities:

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records.

  • Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.

  • Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.

  • Completing training assignments to ensure the necessary technical skills and knowledge.

  • Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.

  • Training others on SOPs, Work Instructions to successfully complete manufacturing operations.

  • Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.

  • Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

Physical Demands:

  • Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.

  • Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.

  • Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.

  • Bend and Kneel - Required to bend or kneel several times a day.

  • Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.

  • Moving Head and Neck Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.

  • Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.

  • Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.

  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.