- 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) in 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.
- Supervise the center's Quality Assurance Unit employees.
- Responsible for working through multiple projects and managing multiple competing priorities.
- Other duties as assigned
- 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.
- Must be fully signed off and capable of performing the duties of the Manager of Quality Assurance.
- Demonstrate expertise in interpreting cGMPs, FDA regulations, and SOP development, as well as an understanding of quality principles.
- Good oral and written communication skills.
- Ability to work independently with little supervision.
- Strong verbal and written communication skills.
- Proficiency with computers.
- Must have explicit attention to detail.
- Must have excellent analytical skills, organization skills, and follow-up.
- 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.
- Typical work environment with moderate noise level.
- May be exposed to freezing temperatures for short periods of time.
- Occupational exposure to bloodborne pathogens.
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Description
Job Description
Job DescriptionThe Manager of Center Quality Assurance is responsible for the daily oversight of the center's Quality Management system.
RESPONSIBILITIES
QUALIFICATIONS
