Manager Center Quality Assurance

<p>Essential Job Responsibilities and Duties<span>  </span><br />• Facilitating and evaluating center and equipment readiness<span>  </span><br />• 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<br />• Oversee daily actions that facilitate product collection (sample collection and submission; testing results, staging)<br />• Assist the Quality Assurance Unit (QAU) ensuring donor center records are complete and accurate<br />• Ensure shipments (sample, product, waste, etc.) are managed and labeled accurately<br />• The interpretation and application of SOPs; and, ensuring SOP revisions are implemented correctly, efficiently and effectively<br />• The receipt, approval and release of donor center supplies.<br />• Assist Center Management and Training Coordinator to ensure training is conducted and documented as directed, review and prepare for inspections/audits, and to develop CAPA, and other quality duties as assigned<br />• Oversee and manage the center’s Deviation Management System to ensure adequate investigations are completed, accurate root cause(s) identified, and CAPA process is identified and managed<br />• Track and trend the center’s quality and operational metrics with respect to applicable SOPs.<br />• Perform periodic self-assessments of the center’s quality and compliance<br />• Administratively oversee the performance and submission of the center’s Proficiency Testing process (Note: this does not replace any CLIA regulated process)<br />• Manage the document control process of the center and suggest necessary SOP changes as required<br />• Supervise the center’s Quality Assurance Unit employees<br />• Work effectively and partner with the Field Quality, Operations support, Center Director and Corporate staff to ensure daily operations are in full compliance<br />• Maintain an open line of communication with Management<br />• Responsible for working through multiple projects and managing multiple competing priorities.<br />• Other duties as assigned<br />Qualifications<br />• Bachelor’s Degree in a scientific discipline, life sciences or related discipline preferred or<br />(12) twelve months experience related to quality, regulatory or related industry provided that the experience was obtained in a regulated environment.<span>  </span><br />• Necessary education/experience may be substituted for the position with approval from the Director of Quality Assurance or VP of Quality Assurance.<br /><br />Requirements<br />• Must be fully signed off and capable of performing duties of the Manager of Quality Assurance<br />• Demonstrate expertise in interpreting cGMPs, FDA regulations, SOP development, as well as an understanding of quality principles<br />• Good oral and written communication skills<br />• Ability to work independently with little supervision<br />• Demonstrated ability to define problems, collect data, establish facts and draw valid conclusions<br />• Strong verbal and written communication skills<br />• Must have above average problem-solving and decision-making abilities<br />• Proficiency with computers<br />• Must have explicit attention to detail<br />• Must have excellent analytical skills, organization skills, and follow-up<br />• Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals<br />• Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables<br /><br /><br />Physical Requirements<br />• Use hands to handle or feel objects, tools, or controls; reach with hands and arms; and talk or hear<br />• Frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee<br />• Manual dexterity to perform all phases of donor plasmapheresis<br />• Ability to stand for extended periods of time for up to four (4) hours at a time<br />• Ability to sit for extended periods of time for up to (4) hours at a time and view a computer screen<br />• Ability to lift, tug, pull up to fifty (50) pounds<br />• Ability to travel by plane, or car as required to train or assist other centers as needed.<br /> </p>