Quality Assurance Supervisor (New Center) - Octapharma Plasma, Inc. (California)
Want to be a part of something exciting? Help Octapharma Plasma open our next Donor Center! At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding.
We own and operate plasma collection centers throughout the United States. Our services are critical to the development of life-saving patient therapies utilized by thousands of patients all over the world. Octapharma Plasma is a subsidiary of one of the world’s largest plasma products manufacturers, Octapharma AG, a Switzerland-based company that has been committed to patient care and medical innovation for over 30 years. Octapharma employs over 5,000 people and has biopharmaceutical experience in 70 countries worldwide.
Quality – Regulatory - Operations
Job Responsibilities
We are seeking a Quality Assurance Supervisor to join our growing biopharmaceutical company and assist in opening our newest Donor Center. Reporting into the Regional Director of Operations, this position is responsible for the overall quality program of the Donor Center. You will provide advice and consultation to other management team members regarding daily quality assurance issues including donor suitability and/or product quality.
Additional responsibilities of the Quality Assurance Supervisor role include:
• Determines if quality activities and manufacturing records are in compliance with SOPs and regulatory requirements; determines the need for corrective actions; ensures proper documentation and determines effectiveness of the action
• Performs final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications
• Performs regular quality compliance audits of the center activities, i.e., manufacturing records, donor processing, plasma collection, product sampling, processing storage and shipping
• Provides direction and oversight of Quality staff ensuring required quality tasks are completed within required time frames
• Identifies desired career path goals of the Quality staff and provides coaching and mentoring to aid the Quality staff in achievement of career goals
• Prepares staff and co-hosts both internal and external audits
• Collaborates with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames
• Ensures that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all center staff
• Obtains certification as a Quality Trainer; responsible for training of center Quality Assurance staff
• Analyzes tracking and trending data; determines appropriate actions to improve trending