p>• Must be fully signed off and capable of performing duties of the Manager of Quality Assurance • Demonstrate expertise in interpreting cGMPs, FDA regulations, SOP development, as well as an understanding of quality principles • Good oral and written communication skills • Ability to work independently with little supervision • Demonstrated ability to define problems, collect data, establish facts and draw valid conclusions • Strong verbal and written communication skills • Must have above average problem-solving and decision-making abilities • Proficiency with computers • Must have explicit attention to detail • Must have excellent analytical skills, organization skills, and follow-up • Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals • Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. • Facilitating and evaluating center and equipment readiness • Responsible for all quality personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination, and the maintenance of all quality personnel records • Oversee daily actions that facilitate product collection (sample collection and submission; testing results, staging) • Assist the Quality Assurance Unit (QAU) ensuring donor center records are complete and accurate • Ensure shipments (sample, product, waste, etc.) are managed and labeled accurately • The interpretation and application of SOPs; and, ensuring SOP revisions are implemented correctly, efficiently and effectively • The receipt, approval and release of donor center supplies.