Quality Assurance - Senior Specialist

Function as the lead auditor both independently and as part of a team to ensure compliance to GxPs, client policies, international guidelines and departmental SOPsProactively identify and analyze quality indicators and data to identify potential risks and create risk management strategiesConduct a wide range of audits (such as GLP, BA/BE/VCA)Serve as a technical resource to resolve GLP or regulated lab area issues, actively participate in the development of QA procedures, guidance documents and audit toolsEscalate quality issues in a timely manner to leadership, participate in root cause and CAPAsProvide timely resolution of findings and reports to appropriate personnel and leadershipStay away of regulatory citations and other pertinent information to distribute to personnel, may participate in compliance awareness sessionsTrain other QA colleaguesProvide inspection management support as neededComplete other projects or assignments as directed by management