Sr. QA Specialist, Manufacturing

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 Senior Quality Assurance Specialist supports the day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change controls, batch record review, batch disposition, and data integrity in support of biologics/gene therapy manufacturing operations.

ESSENTIAL JOB FUNCTIONS 

• 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 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 function trainings to junior QA specialists.
• Support internal and external audits and inspections.
• Lead and support the Quality and production operation continuous improvement.
• Other duties as assigned.

SPECIAL JOB REQUIREMENTS

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

KNOWLEDGE, SKILLS AND EXPERIENCE

6-8 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 and QA oversight

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

Position requires incumbent to be capable of lifting 25 pounds and must be able to demonstrate ability to gown aseptically

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 Be flexible to shift hours to support manufacturing (Overtime and holiday work might be scheduled) Essential

 

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

• Occasionally required to walk

Communication

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

 

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.