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

WORKING AT GENEZEN

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.

In support of biologics/gene therapy manufacturing operations, the Senior Quality Assurance Specialist champions collaborative day to day floor support, batch record review, and 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), excursions, Out of Specifications (OOS), change controls, and upholding data integrity.

This role is aligned with the Manufacturing Friday-Sunday shift and the schedule is Friday-Sunday, 6am-6:30pm.

• 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.

• Adaptability required as work schedule may change based on business needs.
• Criminal background check required.
• Other duties as assigned

• BS in science or engineering discipline
  - Desired
• 8+ 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

The anticipated annual salary range for the Sr. QA Analyst is $100,000-$115,000. Salary determined based on relevant experience, skills and education.

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;…