LIFELINE Blood Services
The Quality and Regulatory Services Manager reports to the Director of QRS and is responsible for the quality and regulatory affairs, duties, and responsibilities by reviewing department procedures, forms, training documents, product and equipment quality control (QC), change control processes, and validations, and assist with the development, as necessary. Reviews applicable regulations and standards from FDA, AABB, CLIA, OSHA, NRC, State of Tennessee, and manufacturers to ensure compliance. Personnel Training: Perform Good Manufacturing Practice (cGMP) and safety training and assist in inter-departmental training and competency evaluation. Maintain compliance by enforcing applicable regulations and standards set by regulatory agencies and submit appropriate reports when required. Document Control: Maintain proficiency in Document Control within MediaLab. Able to revise and create SOPs, Forms, and Job Aids. Create, perform, and review validations. Manage the overall deviation management program to include investigation, root cause, analysis, corrective and preventative actions, and documentation. Responsible for developing, tracking, monitoring, and reporting quality indicators. Monitor and conduct trend analysis of quality indicators. Process improvement, including change control and corrective/preventative actions. Please click here to view the full job description and apply.