Sr. QA Specialist, Manufacturing

Job Description

Job Description

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

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

EssentialGood problem-solving skillsEssential

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

EssentialBe 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

Movement

Communication

GENEZEN'S CURES VALUE-BASED COMPETENCIES

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.

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.