Supervisor, Quality Assurance (2nd Shift)

Overview At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. Role Responsibilities Proficiency of internal manufacturing and quality assurance procedures as well as compliance and regulatory requirements. Proficiency in Batch Record reviews for conformance to established procedures and critical process parameters. Provide leadership and guidance to quality inspectors and ensure adequate coverage through dynamic scheduling for APA and Grade D/CNC areas throughout the shift. Ensure training is completed for direct reports. Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues. Ability to solve problems and suggest solutions when escalating. Ability to successfully don a sterile gown and complete gowning qualification requirements and maintain them to support critical aseptic processing areas (APA). Participate in media fills as Quality Observer when needed. Initiate incidents in QTS as applicable. Train on performing line clearance / verification of critical areas. Perform daily on-line auditing in the APA to ensure the area is maintained in an audit‑ready state. Aid in Root Cause Analysis and identification of Preventive Actions to support manufacturing investigations. Assist in identifying continuous improvements of Standard Operating Procedures (SOPs) and Master Batch Records. Perform other Quality Assurance functions as needed. Attend and participate in daily shift huddles/Gemba meetings. This is a 2nd shift position, 2 pm–10:30 pm, Monday through Friday. Basic Qualifications Education: BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science‑related discipline. In lieu of a bachelor’s degree, an associate’s degree with 2+ years of experience is acceptable. Experience: Minimum 3 years of pharmaceutical experience or an equivalent combination of education and experience. 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 inter‑departmental teams. Non‑Standard Work Schedule, Travel or Environmental Requirements Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis. Must be able to simultaneously multi‑task across multiple capabilities, functions and manage competing priorities, including frequent email and phone communications and attending multiple meetings and conference calls. Must be able to work effectively under and manage strict production, time, and performance deadlines. Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays. California residents should review our Notice for California Employees and Applicants before applying. Kindeva Drug Delivery 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. #J-18808-Ljbffr