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.
In support of biologics/gene therapy manufacturing operations, the Quality Assurance Specialist II engages in collaborative day to day floor support and batch record review which ensures timely and compliant batch disposition. This role is accountable for all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), change controls, and upholding data integrity.
This role is aligned with the Manufacturing 2nd shift and the schedule is Monday-Friday, 3pm-11:30pm.
ESSENTIAL JOB FUNCTIONS
SPECIAL JOB REQUIREMENTS
KNOWLEDGE, SKILLS AND EXPERIENCE
BS in science or engineering discipline
Desired
3-5 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Essential
Experience working in a cGMP manufacturing environment
Essential
Well versed in cGMP/ICH/FDA/EU regulations and guidelines
Essential
Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint ect.)
Essential
Strong written and verbal communication skills to interact with cross function teams
Essential
Strong organizational skill
Essential
High level of attention to detail
Essential
Good problem-solving skills
Essential
Capable of working with minimal supervision
Essential
Ability to work well with diverse groups
Essential
Ability to multi-task in a fast-paced environment with challenging timelines
Essential
COMPENSATION RANGE:
The anticipated annual salary range for the QA Specialist II is$80,000-$95,000. Salary determined based on relevant experience, skills and education.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment:
Movement:
Vision:
Communication
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
ADDITIONAL DETAILS
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 museum--to 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.
Founded in 2014 in Indianapolis, IN, Genezen is a best-in-class gene therapy CDMO with over a decade of experience supporting the cell and gene therapy manufacturing market worldwide. With capabilities across vector-modalities (AAV, lentiviral, retroviral, and others), Genezen partners with innovator organizations to deliver potentially life-saving gene and cell therapies – from concept to commercial. With flexible and customer-centric programs, Genezen tailors its partnership-model approach to all sizes and stages of organizations, to make viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen’s state-of-the art Lexington, MA site holds multiple global regulatory licenses, including with the FDA, EMA, Health Canada, and MFDS Korea, in support of the active manufacture of a commercial viral vector-based product. Our Indianapolis, IN site provides cGMP manufacturing for viral vectors and is currently supporting a program entering a pivotal clinical trial.
