The QA Senior Associate plays a critical role in batch record review and the disposition of clinical and commercial BDS lots for Clients's RNA therapies. This position is a key member of the QA team, ensuring CMO batch compliance with FDA, ICH regulations, and internal procedures. Responsibilities include deviation and investigation review, closure, and data entry, as well as periodic tasks such as SOP and policy updates to support continuous improvement initiatives.
Primary Responsibilities:
Collaborate as an active member of the Quality Assurance Operations Team and work closely with technical and analytical teams.
Provide support during CMO batch production for Manufacturing and Testing Operations, ensuring timely and compliant handling of unexpected events.
Review and approve critical documents, including CMO manufacturing batch records, lot disposition documentation, Certificates of Analysis, deviations, investigations, and OOS records to support product release.
Perform data entry for lot release cycle times to generate metrics.
Address diverse challenges using sound judgment and risk-based decision-making.
Keep management informed of critical issues.
Maintain a state of continuous inspection readiness.
Qualifications and Skills:
BS/MS in Biology or a related discipline with 9+ years of experience in a cGMP environment, demonstrating strong knowledge of FDA, EU, ATMP, and JP regulations.
Experience in establishing GMP operations and systems in a new facility is a plus.
Highly detail-oriented with excellent communication skills, capable of interacting professionally and proactively with clients and management teams.
Proficiency in Microsoft Outlook, PowerPoint, Word, Excel, and GMP system programs and spreadsheets is required.
Ability to follow written procedures and effectively read, write, and communicate in English.
This role is ideal for candidates who thrive in a collaborative, fast-paced environment and are committed to maintaining high standards of compliance and quality assurance.