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