Inotiv

QA Engineer

• Leads a Quality Assurance team to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and CDC
• Provides guidance, support, mentoring, and training to direct reports
• Prepares and revises documents that support regulatory and statutory requirements
• Applies rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
• Prepares customer complaint metrics and KPIs, and analyses trends
• Facilitates root cause analysis on significant customer complaints and/or complaint trends
• Assesses nonconformance reports with regards to the level of risk to product quality
• Analyzes trend data to identify key areas of opportunities that impact product quality
• Tracks and trends performance of quality systems and prepares and presents status reports for key performance indicators to management
• Facilitates and reviews customer correspondence associated with complaints
• Reviews and approves complaint investigations and associated RCAs and CAPAs
• Leads and participates in Continuous Improvement projects
• Leads and participates in the Document Control process
• Reviews and approves changes to controlled documentation (policies, procedures, etc.)
• Leads and participates in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related procedures
• Leads and participates in customer, supplier, internal and regulatory audits
• Performs compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
• Collaborates cross-functionally to address audit findings by established deadlines
• Conducts training for new hires as required
• Promotes and complies with quality assurance procedures
• Promotes and complies with health and safety procedures
• Six Sigma Green Belt or higher is required
• Regular business travel is required.

Senior Manager, Quality Assurance