Sr. QA Specialist (Fri-Sun 6am-6:30pm)

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.

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.

• •Oversee and provide regulatory compliance guidance during on-the-floor manufacturing activities.
• •Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
• •Review and approve documents from Manufacturing, such as SOPs, batch records, logbooks, training forms, etc.
• •Perform Quality walkthroughs to maintain inspection readiness environment.
• •Participate in batch disposition activities.
• •QA support of drug product aseptic fill operations and vial visual inspections.
• •Assist in deviation investigations, CAPA and Change Control implementations.
• •Provide QA operation functional trainings, guidance, and mentorship to junior QA specialists.
• •Support internal and external audits and inspections.
• •Lead and support the Quality and production operation continuous improvement.

8+ years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment

Essential

While performing the duties of this job, the employee is required to meet the following physical demands:

• •Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• •Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• •Occasionally exposed to moving mechanical parts; caustic chemicals; hazardous waste.
• •Occasionally exposed to loud noise levels
• •Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

• •Frequently required to stand; sit.
• •Occasionally required to walk; climb or balance; and stoop/crouch.

• •Frequently utilize close vision and the ability to adjust focus

• •Frequently required to communicate by talking, hearing, using telephone and e-mail

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.

• •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
• •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

• •Nothing in the job description for this role restricts management’s right to assign or reassign duties and