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

Job Summary

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.

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 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.

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

• 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