Overview
Principal Associate – Quality Assurance – Device Complaints Jobs in Indianapolis, IN at Lilly
Company Overview
Surgenex® is an industry-leading biotechnology firm dedicated to the development and commercialization of placental tissue and musculoskeletal-based implants. We pride ourselves on meeting stringent quality and safety standards while delivering innovative solutions through our comprehensive processing capabilities.
Summary
The Quality Control Coordinator III (QPC) supports Surgenex’s mission by providing regulatory support and safeguarding the quality, safety, and integrity of human tissues processed and stored. This role involves assisting with quality control measures, monitoring tissue processing, conducting tests, and ensuring compliance with regulatory standards for transplantation and research purposes.
Responsibilities
Assist in developing and implementing quality control procedures for tissue processing, including real-time QC and environmental monitoring.
Oversee tissue processing, ensuring adherence to protocols (temperature, humidity, times).
Support Regulatory by assessing compliance and identifying areas for improvement.
Conduct QA reviews of records (batch, donor) for accuracy and compliance.
Assist with tissue final release (labeling, packaging).
Stay updated on tissue banking regulations.
Analyze quality control data, create metrics, and prepare reports.
Participate in continuous improvement.
Enhance quality control processes for efficiency.
Inspect products and perform real-time rework as needed.
Investigate non-conformances and develop corrective actions.
Train staff on quality control procedures and ensure compliance.
Other duties as assigned.
Qualifications
Accuracy & Detail Oriented
Active Listening & Communication
Conflict Resolution & Teamwork
Customer Oriented & Diversity Oriented
Honesty / Integrity & Responsible
Organized & Time Management
Self-Confident & Adaptability
Compliance & Problem Solving
If you are driven by excellence in biotechnology and eager to contribute to innovative solutions, we invite you to apply today to join our dedicated team at Surgenex.
Job Type: Full-time
Pay: $42,000.00 – $52,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Work Location: In person
Title: Principal Associate – Quality Assurance – Device Complaints
Company: Lilly
Location: Indianapolis, IN
