Genezen

Sr. Associate, Quality Operations

Indianapolis, IN · Senior

Work authorization requiredDetected 41 days ago

Clinical TrialsGMPFDA RegulatoryCRISPRLeadershipCommunicationCollaborationProblem SolvingMentoringAdaptability

About the role

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients.
We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company.
Address terms of product quality and conformance to regulations and Genezen quality policies/procedures.

Adaptability required as work schedule may change based on business needs
Criminal background check and drug screen required
6+ years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role
Experience working in with early phase clinical trial production and testing
Previous experience with a startup CDMO and/or in the field of Gene Therapy
Frequently required to stand
Occasionally required to walk

Bachelor's degree in science or related field
Familiarity of eQMS systems such as Veeva
Knowledge of clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms
Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms
Occasionally exposed to loud noise levels
Regularly sit for long periods of time
Frequently required to stand; sit; 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
Frequently utilize close vision and the ability to adjust focus
20/20 or Corrected 20/20 Vision
Frequently required to communicate by talking, hearing, using telephone and e-mail
Paid vacation days, amount based on tenure

Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence.
Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
Develop and optimize SOPs and other controlled documents for the Quality Assurance department.

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.
Many people have worked in environments where you feel like just another nameless part of an enormous machine.
Genezen is different.
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.
Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities.
Help in the development of QA people and teams.
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
We are dedicated to delivering quality results and upholding ethical principals.

en is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas

This listing is sourced directly from Genezen's careers page and normalized into a canonical job model.