Overview
PM Inspector (Sun-Wed 5:30 PM – 5:30 AM) Jobs in Irvine, CA at B. Braun Medical Inc.
Quality Assurance Specialist
Company Description
HeartWorks develops autologous, stem-cell based products to improve outcomes for congenital heart disease (CHD) patients. Our team is engaged in all aspects of product development from basic research to clinical grade manufacturing and clinical trial execution. Our current product pipeline is focused on ipsc-derived cardiac cells.
Job Summary
This role would be focused on cell therapy manufacturing activities, but may also provide support for pre-clinical and clinical activities. This team provides oversight of daily activities to ensure compliance with the quality management system. Participates in ongoing monitoring of daily activities and continuous improvement activities to ensure compliant practices and timely corrective/preventative actions. Perform QA/regulatory review of standard operating procedures, protocols, and technical reports.
Duties and Responsibilities
1. Carry out ongoing quality assurance oversight activities, including:
Document control
Continual improvement activities, including change control and corrective/preventive actions
Incident management
2. Review manufacturing batch records for completeness and accuracy
3. Assist in investigation and resolution of manufacturing deviations and non-conforming products, including determination of appropriate product disposition and rationale.
4. Collect, review, and summarize performance of quality metrics to ensure operational standardization and regulatory compliance.
5. Follows standard data collection processes, analyzes data, reports metrics and prepares reports as needed
6. Provides coaching and guidance to all staff on quality concepts.
7. Perform other duties as required based on company needs.
Qualifications
Required:
Bachelor’s degree with 2+ years experience in Quality Assurance, Pre-clinical animal studies, and/or Clinical trial execution, OR Associate degree and 5+ years experience
Solid understanding of Quality system fundamentals
Ability to apply quality concepts across different functional areas in a flexible manner
Ability to troubleshoot, problem solve, and make decisions independently.
Good inter-personal skills and team member.
Working knowledge of Microsoft Office.
Occasional light to moderate lifting.
Preferred:
Familiarity with concepts of Good Laboratory Practice, Good Clinical Practice, or both
Prior work in cell therapy or pharmaceutical environment
Familiarity with software qualification and implementation
Cell culture experience
Job Type: Full-time
Pay: $35.00 – $40.00 per hour
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible schedule
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Weekends as needed
Ability to Commute:
Rochester, MN 55901 (Required)
Ability to Relocate:
Rochester, MN 55901: Relocate before starting work (Required)
Work Location: In person
Show more
Title: PM Inspector (Sun-Wed 5:30 PM – 5:30 AM)
Company: B. Braun Medical Inc.
Location: Irvine, CA
