Quality Assurance Supervisor
BPL Plasma is dedicated to the collection of plasma for life-saving therapies. For over 25 years, our product has been used to treat immune deficiencies and bleeding disorders, in addition to shock, trauma, and burn patients. BPL Plasma currently operates 34 FDA licensed blood plasma collection centers throughout the United States. We are opening new centers and growing rapidly in order to provide even more life-saving treatments to those in need.
This Quality Assurance Supervisor is responsible for promoting quality standards within the center and ensuring that quality policies and procedures are followed by center personnel. The QA Supervisor works closely with Management and training staff to ensure consistent compliance with FDA, EU, OSHA, PPTA, customer and other regulatory authorities. The QA Supervisor has the authority to stop production and/or plasma shipment release based on his/her professional judgment and discretion. A professional attitude must be displayed by the QA Supervisor at all times, which includes maintaining confidentiality of all personnel, donor and center related information. This position requires the ability to maintain effectiveness and adjust appropriately when experiencing changes in work tasks or work environment.
• Review manufacturing activities, determine if records are in compliance with SOP and regulatory requirements, and ensure corrective actions as needed.
• Perform final QA review and release for all product shipments and associated documents in order to ensure shipments meet customer specifications.
• Communicate with management regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality; develop and implement corrective actions when necessary.
• Prepare staff and co-host customer, regulatory, and corporate audits of the center. In conjunction with management complete all audit responses, including corrective/preventive action, and ensure that responses are submitted in a timely manner.
• Participate in regularly scheduled staff meetings and conduct regular meetings with center management and quality staff.
• Work as a team with management to support and assist center with compliance and Key Performance Indicators.
• Perform ongoing focused audits to ensure employees correctly perform procedures; identify deficiencies and work closely with training staff to correct any issues noted.
• Assist management and training staff in communicating SOP and regulatory changes to involved staff and ensure documentation of training is complete.
• Coordinate scheduling with management and conduct training of center QA staff.
• Analyze tracking and trending data and determine appropriate actions to improve trending.
• Review center logs and records to ensure information is accurate and/or legible as outlined in the Quality System SOP and ensure corrections are made as needed.
• Review incoming softgoods and medical supplies to ensure accurate receipt and suitability for use.
• Perform other related center duties, as assigned.