Blood Assurance is seeking a Director of Quality Assurance to work in our downtown Chattanooga facility.
The Director monitors the facility’s compliance with all applicable standards and regulations and is responsible for the oversight of all activities relating to product quality. Determines appropriate Standard Operating Procedures (SOP’s) exist for all manufacturing procedures and staff is appropriately qualified, trained, and competent. Evaluates reports of manufacturing errors and accidents, customer complaints, and variations from SOP’s. Ensures records provide a complete and accurate history of all work performed. Audits all manufacturing systems to ensure compliance with applicable regulations and to identify opportunities for improvement. Determines new or revised processes are validated and equipment is appropriately qualified and validated.
Qualified applicants should possess: Bachelor’s degree with major in biological science or related field. Five years of experience in blood banking, biologics manufacturing or regulations and compliance. Extensive knowledge of AABB, FDA, CLIA, OSHA, and state Departments of Health requirements. Knowledge of quality control, SOP development, and auditing skills.
Certification by American Society of Quality as a Certified Manager of Quality and Certified Quality Auditor desirable.
Qualified candidates are encouraged to submit an online application at www.bloodassurance.org. Blood Assurance is an EOE and Tobacco Free Workplace.