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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
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 growing rapidly in order to provide even more life-saving treatments to those in need.
Purpose: The purpose of this position is to manage donor center QA staff and ensure quality standards within the center. The Center Quality Manager has the authority to stop production and/or plasma shipment release based on his/her professional judgment and discretion. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
1. Manages center Quality Assurance staff to include training, performance evaluation, career development, compensation administration and progressive discipline as needed per company policies and procedures. 2. Coordinates the scheduling of the center Quality Assurance staff. 3. Guarantees data integrity by reviewing all aspects of the manufacturing process to ensure the completeness, and accuracy of records and documents within the quality systems. 4. Analyzes deviation tracking and trending data and implements appropriate CAPA to improve compliance and quality. 5. Plans and presents quality topics during regularly scheduled staff meetings and hosts a weekly QA staff meeting with Operations Management and Quality Assurance staff. 6. Manages on time resolution of error investigations and CAPA. 7. Drives center level CAPA initiatives generated from tracking and trending analysis. 8. Ensures final QA review and release for all product shipments and associated documents to ensure shipments meet regulatory customer specifications as needed. 9. Co-hosts customer, regulatory, and corporate audits of the center. In conjunction with regional and center management, completes all audit responses, including corrective/preventive action, and ensures that responses are submitted on time. 10. Partner with Training Coordinator to ensure that new hire and SOP training occurs and is effective. 11. Other job-related responsibilities as required.
Qualifications: 1. Bachelor’s degree in life science or related field preferred.
For over 25 years, BPL has been a leader in the plasma industry. We are recognized both in the United States and in other countries for the consistently high quality of product we provide to pharmaceutical companies around the globe. BPL Plasma, Inc. is a subsidiary of Bio Products Laboratory Ltd, who manufactures a wide range of plasma products. Located in Elstree, near London (UK), we are commi...tted to research and development to maintain a key position in a constantly changing market in the 21st century.
BPL has 34 plasma centers throughout the United States. All of our plasma centers are FDA regulated and follow all industry guidelines. We pride ourselves on operating modern plasma facilities staffed with trained and friendly personnel.
In addition to collecting life-saving plasma, BPL compensates donors for their time, resulting in the infusion of thousands of dollars in to the local communities surrounding the centers. Moreover, BPL centers are involved in local area Chambers of Commerce and sponsor community activities such as neighborhood cleanups.