Supervisor, Quality Assurance (2nd Shift)

The Role

The QA Supervisor – Aseptic plays a crucial role in ensuring the quality and safety of products at Kindeva. Reporting to QA Management, this position oversees Quality Inspectors and ensures compliance with aseptic processing principles and regulations.

Responsibilities

• Facilitate timely resolution and escalation of manufacturing deviations and communicate to Production and QA Management.
• Lead and guide Quality Inspectors, ensuring adequate coverage in APA and Grade D/CNC areas.
• Ensure training completion for direct reports and generate daily written shift reports for Quality and Production Management.
• Solve problems and suggest solutions when necessary.
• Perform daily on-line audits in APA to maintain audit readiness.
• Aid in Root Cause Analysis and identify Preventive Actions for manufacturing investigations.
• Support continuous improvement of SOPs and Master Batch Records.
• Attend and participate in shift huddles/Gemba meetings.

Qualifications

• Education: BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or related field. Associate’s degree with 2+ years of experience may substitute.
• Experience: Minimum 3 years of pharmaceutical experience or equivalent. Experience at an aseptic manufacturing site preferred. 1 year of supervisory experience is preferred.
• Produces quality work with minimal guidance. Must be able to work in a team environment and across interdepartmental teams.
• Non-standard work schedule, travel or environment requirements: Requires regular onsite attendance, 2pm-10:30pm, Monday through Friday. Must be able to work beyond typical work hours, including weekends and holidays.

Benefits

Position requires regular onsite attendance. This is a 2nd shift position, 2pm-10:30pm, Monday through Friday. Kindeva is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.