The posting
Shift: Monday–Friday | 2:00 PM – 10:30 PMWork Location: Onsite – Sterile Product Manufacturing (SPM) 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. Role Responsibilities Quality Leadership and Team Coordination
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.
Aseptic Manufacturing and Quality Oversight
Ensure quality inspections and batch record reviews are performed in accordance with established standards, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and applicable regulatory requirements.
Review batch records for conformance to established procedures and critical process parameters.
Demonstrate proficiency in internal manufacturing and quality assurance procedures, as well as applicable compliance and regulatory requirements.
Successfully don sterile gowning attire and complete and maintain gowning qualifications to support critical Aseptic Processing Areas (APA).
Participate in media fills as a Quality Observer when needed.
Train on performing line clearance and verification of critical areas.
Perform daily online audits in APA to ensure areas remain in an audit-ready state.
Deviation Management and Continuous Improvement
Partner with Production and Quality Assurance Management to identify and resolve manufacturing and quality issues, escalating critical concerns as appropriate.
Initiate incidents in the Quality Tracking System (QTS), as applicable.
Support manufacturing investigations through Root Cause Analysis and identification of preventive actions.
Assist in identifying continuous improvements to Standard Operating Procedures (SOPs) and Master Batch Records.
Coordinate and/or support changes to SOPs, specifications, and batch records as applicable.
Support quality event documentation and change management activities as required.
Review quality data for consistency with established policies and procedures and contribute to problem-solving and continuous improvement initiatives.
Additional Quality Assurance Support
Maintain working knowledge of applicable quality assurance standards, regulations, and manufacturing requirements.
Perform other Quality Assurance functions as needed.
Basic Qualifications Education
Bachelor's or associate's degree in a technical or science-related discipline, with relevant experience and/or training, or an equivalent combination of education and experience.
Required Experience
Minimum of two years of aseptic manufacturing experience.
Preferred Experience
Supervisory experience in a pharmaceutical, combination product, or medical device manufacturing environment.
Experience with TrackWise and inventory management systems such as SAP or PRISM. Experience with comparable electronic quality management systems or other relevant electronic systems may be considered in lieu of direct TrackWise experience.
Skills and Competencies
Working knowledge of aseptic processing principles, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
Ability to produce quality work with minimal guidance.
Ability to work effectively in a team environment and collaborate across departments.
Ability to identify and resolve quality issues, recommend solutions, and escalate concerns appropriately.
Work Environment and Schedule Requirements
Position requires regular onsite attendance and cannot be performed remotely or on a telecommuting basis, whether temporary, short-term, or long-term.
Must be able to manage multiple responsibilities, functions, and competing priorities, including site and functional responsibilities, frequent email and phone communications, and participation in meetings and conference calls. These activities may extend beyond core working hours or time onsite.
Must be able to work effectively under strict production, time, and performance deadlines.
Must be willing and able to work beyond regularly scheduled hours as needed, including weekends and holidays.
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