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The Principal Quality/GxP Auditor is responsible for developing compliance plans, providing mentorship, supporting audits, and ensuring client compliance with industry regulations. This role requires expert knowledge of GxP regulatory requirements and FDA laws, along with the ability to deliver industry lectures and training.
Quality Specialist responsible for providing quality oversight and support to site Cell and Gene Therapy operations. Lead QA efforts for establishing new programs, batch disposition activities, and product release. Review manufacturing documents, provide technical training, and support quality agreements. Participate in compliance activities, continuous improvements, and process optimization initiatives.
The Strategic Sourcing Global Source to Order Process Excellence Senior Manager role will lead initiatives to strengthen Strategic Sourcing capabilities in key areas such as process improvement, policies and governance, technology assessment and implementation, analytics, supplier relationship management, competitive bidding (RFx and e-auctions) and training and development activities.
The CQV Engineer is responsible for authoring and reviewing SOPs, Equipment Requirements Specifications, and managing equipment maintenance. They troubleshoot manufacturing issues, conduct testing, and collaborate with cross-functional teams to drive continuous improvement efforts. The role requires a Bachelor's Degree and 3+ years of experience in calibrations and maintenance activities within the regulated industry, with technical aptitude and strong communication skills.
Provide IT CSV support to implement and validate electronic systems in accordance with corporate policies and procedures. Collaborate with stakeholders for implementation and development changes. Review and approve documentation associated with validated computer systems. Engage in Quality process improvement initiatives. Provide guidance on compliance requirements for projects.
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