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

Genezen•Lexington, KY

4d•Onsite

About The Position

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.

Requirements

BS in science or engineering discipline
8+ 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

Responsibilities

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.