Supervisor, Quality Assurance (2nd Shift)

About the role

Our Work Matters At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The QA Supervisor – Aseptic will be primarily based in the Sterile Product Manufacturing (SPM) building and will plan, coordinate, and oversee the activities of Quality Assurance colleagues supporting aseptic manufacturing operations. This role is responsible for supervising Quality Inspectors, ensuring appropriate staffing and quality oversight throughout the shift, and verifying that quality inspections and batch records meet established standards, procedures, and regulatory requirements, including Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). The ideal candidate will possess a working knowledge of aseptic processing principles, including aseptic behaviors, facility controls, and applicable compliance and regulatory requirements. The supervisor will partner closely with Production and Quality Assurance Management to identify and resolve manufacturing issues, facilitate timely deviation management and escalation, and maintain quality and compliance throughout aseptic operations.

Responsibilities

• Supervise, plan, and coordinate the daily activities of Quality Assurance colleagues, providing leadership and guidance to Quality Inspectors and ensuring adequate coverage through dynamic scheduling for Aseptic Processing Areas (APA) and Grade D/Controlled Not Classified (CNC) areas throughout the shift.
• Coordinate shift personnel activities, including training, vacation schedules, and absences, to ensure adequate Quality Assurance coverage throughout the shift.
• Ensure required training and qualification curricula are completed and maintained for direct reports.
• Address employee-related issues as appropriate and in accordance with company policies.
• Generate daily written shift reports for Quality and Production Management, providing clear and concise details of relevant issues.
• Attend and participate in daily shift huddles and Gemba meetings.
• Ensure quality inspections and