Quality Assurance Manager

Essential Job Responsibilities and Duties

• 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.
• 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
• 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
• Track and trend the center's quality and operational metrics with respect to applicable SOPs.
• Perform periodic self-assessments of the center's quality and compliance
• Administratively oversee the performance and submission of the center's Proficiency Testing process (Note: this does not replace any CLIA regulated process)
• Manage the document control process of the center and suggest necessary SOP changes as required
• Supervise the center's Quality Assurance Unit employees
• Work effectively and partner with the Field Quality, Operations support, Center Director and Corporate staff to ensure daily operations are in full compliance
• Maintain an open line of communication with Management
• Responsible for working through multiple projects and managing multiple competing priorities.
• Other duties as assigned

Qualifications

• Bachelor's Degree in a scientific discipline, life sciences or related discipline preferred or

(12) twelve months experience related to quality, regulatory or related industry provided that the experience was obtained in a regulated environment.

• Necessary education/experience may be substituted for the position with approval from the Director of Quality Assurance or VP of Quality Assurance.

Requirements

• 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

Physical Requirements

• Use hands to handle or feel objects, tools, or controls; reach with hands and arms; and talk or hear
• Frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee
• Manual dexterity to perform all phases of donor plasmapheresis
• Ability to stand for extended periods of time for up to four (4) hours at a time
• Ability to sit for extended periods of time for up to (4) hours at a time and view a computer screen
• Ability to lift, tug, pull up to fifty (50) pounds
• Ability to travel by plane, or car as required to train or assist other centers as needed.