GMP Document Control Specialist (Temp)

Company: Genezen
Location: Lexington
Posted on: February 19, 2026

Job Description:

Job Description Job Description 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. ESSENTIAL ROLE FUNCTIONS 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 SPECIAL ROLE REQUIREMENTS Criminal background check required. Other duties as assigned. EDUCATION / CERTIFICATIONS / LICENSES High school diploma or Equivalent Minimum of 3 years in a GMP environment SKILLS / ABILITIES 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 Relevant trade skills such as plumbing, electrical, HVAC a plus Proven experience operating and maintaining building support functions is a plus COMPENSATION This is a temp position that will be hired through a 3rd party agency. The hourly rate for the position is $30-$35/hr PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Regularly sit for long periods of time Movement Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 10 pounds Rarely lift and/or move up to 25 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES C ommitted to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. U rgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. R esilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. E xecute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. S olutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS Paid vacation days, amount based on tenure Paid sick time 10 observed holidays 2 floating holiday 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the 1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museumto name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Keywords: Genezen, Marthas Vineyard , GMP Document Control Specialist (Temp), Engineering , Lexington, Massachusetts