Quality Assurance Manager

***************************************No Third Party Agencies ************************

Job Summary

We are seeking a dedicated and experienced Quality Assurance Manager with oversight and responsibility for all Quality aspects, including but not limited to FDA & GMP compliance, and compliance of staff to all SOPs and processes. You will be the Quality Assurance point-of-contact during FDA, Supplier Audits, etc. This role is crucial in maintaining the integrity of our products and ensuring customer satisfaction through high-quality standards.

Qualifications:

• High School Diploma or GED
• At least 2 years prior Source Plasma Center experience as the Quality Assurance Manager
• Strong customer service skills and the ability to understand and follow protocol
• Team lead/Supervisor experience
• Possess adequate communication skills and be able to effectively communicate with people of all levels

Responsibilities:

• ​Maintain compliance with Life Plasma SOP, current Good Manufacturing Practices (cGMP), CLIA and other guidelines by reviewing donor and manufacturing records
• Provides advice and consultation to other management team members regarding daily quality assurance issues including donor suitability and/or product quality
• Performs final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications
• Participates in the interviewing during hiring of staff, new hire training and competency testing
• Collaborates with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames
• Analyzes tracking and trending data; determines appropriate actions to improve trending.

Join our team as a Quality Assurance Manager where you will play a key role in ensuring that our products meet the highest standards of quality. Your expertise will help us maintain compliance while continuously improving our processes.