• Responsible for day-to-day operations of Precision Allograft Solutions (Processor for Alamo Biologics) • Maintain compliance with all current Federal, State, and local laws and regulations, including those of the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB). • Manage Quality Assurance reviews and audits. • Resolve customer complaints, investigate problems, develop solutions, and prepare correspondence. • Perform inventory audits of tissue products. • Appoint, supervise, direct, and resolve staff issues. • Approve and maintain Job Descriptions and document staff responsibilities. • Develop, review, and approve employee-training programs. • Perform Validation/Verification activities as needed. • Implement and evaluate all technical policies and procedures. • Serve as the appointed Management with Executive Responsibility (MwER).
• Know the responsibilities of co-workers and perform those activities in the event of their absence.
Education: Bachelor's Degree in Laboratory Science or related discipline Experience: 5 years’ experience in tissue processing, laboratory setting or GMP regulated area experience preferred. Must have working knowledge of PC software applications using Windows, Microsoft Word, Excel, and other software programs as required. Certification/License: CTBS
Must maintain knowledge of HCT/P regulations and standards. Must acquire a working knowledge of donor suitability and acceptable tissue criteria. Must maintain a knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must maintain knowledge of cGMP (current Good Manufacturing Practices) requirements. Must maintain a knowledge of applicable industry standards, including but not limited to AATB, FDA, and ISO.