About the Role
This role provides direct quality assurance support on the manufacturing floor, monitoring processes, reviewing documentation, and addressing quality events to ensure compliance with established standards.
Responsibilities
- Conduct real-time oversight of manufacturing activities to verify adherence to quality protocols
- Review batch records and operational documentation for accuracy and completeness
- Support investigations into deviations, discrepancies, and non-conformances
- Assist in root cause analyses and recommend corrective actions
- Ensure compliance with internal procedures and regulatory requirements
- Collaborate with manufacturing teams to resolve quality issues during production
- Verify proper implementation of quality holds and material quarantine procedures
- Participate in continuous improvement initiatives related to quality systems
- Support audits by providing documentation and on-site assistance
- Monitor change controls impacting manufacturing processes
- Evaluate supplier-related quality events affecting production materials
- Provide input on corrective and preventive actions (CAPA)
- Assist in training personnel on quality documentation practices
- Track and report quality metrics from floor operations
- Ensure timely closure of quality-related tasks and follow-ups
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
On-site position with limited remote flexibility
Team
Collaborative environment within the Quality Assurance department working closely with Manufacturing, Engineering, and Regulatory teams
Why Join Us
- Be part of a growing organization focused on innovative kidney care solutions
- Work in a dynamic environment that values precision, compliance, and patient safety
- Contribute to the success of scalable manufacturing processes for advanced therapies
Physical Requirements
- Ability to stand for extended periods while on the manufacturing floor
- Frequent walking between workstations and production areas
- Occasional lifting of up to 20 pounds as needed
May be available for qualified candidates based on business needs
