QA Specialist II (M-F 3:00pm-11:30pm)

Genezen•Lexington, KY

1d•Onsite

About The Position

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. 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.

Requirements

BS in science or engineering discipline
3-5 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Experience working in a cGMP manufacturing environment
Well versed in cGMP/ICH/FDA/EU regulations and guidelines
Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint ect.)
Strong written and verbal communication skills to interact with cross function teams
Strong organizational skill
High level of attention to detail
Good problem-solving skills
Capable of working with minimal supervision
Ability to work well with diverse groups
Ability to multi-task in a fast-paced environment with challenging timelines

Nice To Haves

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

Responsibilities

Oversee and provide compliance guidance during on-the-floor manufacturing activities.
Work alongside manufacturing teams to ensure current and best practices are implemented.
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 executed batch records, solution lot records, and logbooks.
Participate in batch disposition activities.
QA support of drug product aseptic fill operations and vial visual inspections.
Assist in deviation investigations.
Support internal and external audits and inspections.
Support continuous improvements.