Quality Manager - Plasma Center

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.