Facilities & Engineering Document Control Specialist (Temp)

Genezen•Lexington, MA

12h•$30 - $35

About The Position

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The FAC/ENG Document Control Specialist temp role is responsible for managing the Blue Mountain Regulatory System, which includes the oversight and approval of assets, systems, and equipment. The role also involves assigning system numbers and working with the facilities manager and engineering to create maintenance assessments of work plans and obtain appropriate signatures. The specialist will oversee the Document Control and Archival Process for GMP Facilities and Engineering documents, ensuring compliance with regulatory, quality, and company requirements.

Requirements

High school diploma or Equivalent
Minimum of 3 years in a GMP environment
Mechanical aptitude required
Positive attitude, service oriented, and willingness / ability to perform tasks deemed essential
Attention to detail and an ability to see jobs through to completion
Criminal background check required.

Nice To Haves

Relevant trade skills such as plumbing, electrical, HVAC a plus
Proven experience operating and maintaining building support functions is a plus

Responsibilities

Work with the Facilities Manager and Engineering to create maintenance events and work plans and oversee all corresponding department approvals.
Coordinates maintenance activities.
Assigned maintenance activities.
Schedule maintenance activities.
Close all final maintenance work related.
Update monthly reports related to Maintenance Work Orders and General Work Orders.
Oversee Archive Room operations.
Manage and oversee the Document Control and Archival Process of GMP Facilities and Engineering documents.
Responsible for maintaining an effective document tracking process.
Provide FAC/ENG backroom support during regulatory and/or third-party inspections.
Other duties as they arise
Other duties as assigned.