Senior Quality Assurance Auditor

The GMP Quality Assurance Auditor will report to the Director of the Quality Assurance Department.

This position will be focused on ensuring GMP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and/or participate in all GMP QA audit programs which include both internal and external GMP audits. This position will provide day to day support to cGMPs to manage CMOs, packaging and labeling vendors for clinical trials and commercial manufacturing.

Support in review, approval, and logging of Change Controls, Investigations, Deviations, Incidents, OOS and OOT reports
• Review CAPAs, root cause analysis and Investigations
• Support lead audit planning conduct and report on SKLSI Quality Assurance routine and non-routine audits of activities, data, internal facilities, and processes in GMPs to assure adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements
• Support non-routine audits that will include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope
• Support other auditors in planning, conduct and reporting of audits
• Support in authoring, reviewing, and approving internal controlled documents (SOPs, Policies, Guidelines and Forms) and associated quizzes
• Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
• Participate in regulatory inspections in core and supporting roles
• Proficient in computer software Word, Excel, Access, Power Point, etc.

• A minimum of a bachelor's degree (or equivalent) is
• Expertise in additional compliance disciplines is
• Comprehensive knowledge of the drug development process, applicable regulations (GMP), R&D and commercial practices, and scientific and quality terminology is
• Knowledge of procedural and records management requirements in a regulated industry is preferred.Prior experience in a regulated medical industry (Pharmaceutical and/or CMO) is preferred
• Prior pharmaceutical and quality/compliance related experience is preferred.