Sr. QA Specialist/Auditor - Life Sciences - (Reading, PA)

Our client, a Biotech leader seeks a talented Senior QA Specialist, to be responsible for assuring compliance for in-process and final product of Cell therapy manufacturing. The Sr QA Specialist will be managing Audits/Inspections as well as Quality Systems including Deviations, CAPA and product safety that impact on patient safety. Assignments include: Prepare and review SOPs and other documents for compliance and provide guidance to staff on raw material, in-process and finished product release activities and GMP/GTP Evaluate processes and conduct process improvement/root-cause analyses and facilitates implementation of corrective actions, conducting presentations/communications as needed. Develop and complete deliverables related to QA activities including performing internal/external audits and inspections to prepare for product commercialization/licensing Requirements