Senior Specialist, Quality Assurance
Resilience · West Chester, Pennsylvania, US
A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s...
Job description
A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made . We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary: This position is responsible for all QA activities that directly support execution of the process both within the Operations Teams and in assigned areas outside of Operations. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. Position Responsibilities: Maintain a high level of understanding of relevant production processes and quality systems Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: Change Requests B...