Senior Specialist, Technical Quality in West Chester

As the Senior Specialist, Technical Quality, you will be responsible for providing QA oversight for Sterile Operations and assigned areas, ensuring GMP compliance and timely product and document flow. Supporting batch disposition, quality systems, validation, investigations, change control, supplier and distribution activities, and regulatory interactions., n \n

• Provide QA oversight for assigned production areas, maintaining expertise in manufacturing processes, sterile operations, technology, and applicable GMP quality systems. \n

• Review and approve GMP documentation, including change requests, batch records, SAP release transactions, investigations, validation documents, and SOPs; own batch disposition processes and release or reject incoming materials and product. \n

• Lead QA execution and resolution of quality issues, ensuring timely product disposition and document flow while meeting site objectives and key performance metrics. \n

• Advise and partner with Operations, QC, Supply Chain, project teams, and other Quality groups on quality systems, risk assessments, process improvements, and GMP compliance throughout project planning, execution, and closeout. \n

• Serve as process owner or subject matter expert for assigned processes; analyze quality metrics, monitor performance, and recommend effective practices and strategies in response to evolving regulatory expectations. \n

• Demonstrate independent leadership by influencing teams, holding stakeholders accountable, and training, mentoring, and coaching QA and non-QA colleagues. \n

• Bachelor’s degree in a scientific related field \n

• 5+ years of experience working within a pharmaceutical industry with significant experience in sterile/aseptic manufacturing working within an operations environment and/or quality assurance. \n

• Experience supporting quality investigations, change requests, product and components rereleases, etc. \n

• Demonstrated knowledge of GMP requirements, Quality Systems and the pharmaceutical supply chain environment \n