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This position requires that the selected individual lives in, or is willing to relocate to, the Lexington/Central Kentucky area. Educational qualifications include a minimum of a 4-year medical technologist degree (MT/MLS/CLS), with (ASCP) professional certification. Applicants without this qualification will not be considered.

Kentucky Blood Center is seeking a qualified Quality Assurance Manager to guide and support organizational adherence to standards issued by regulatory agencies and accrediting organizations. The position is responsible for KBC’s compliance with applicable AABB, FDA, CLIA, State, OSHA, EU, and short supply agreement requirements. Reports to the Vice President, Quality and Regulatory Affairs; supervises the QA team.

$1,500 Sign-On Bonus

Essential Job Duties

+ Directs the activities of the QA team, providing training and development; responsible for performance management, coaching, selection and hiring, and general supervision of department.

+ Develops and performs quality system and focused audits to ensure that KBC meets regulatory requirements.

+ Oversees occurrence management program and performs final review of reports to ensure appropriate investigation procedures, corrective action, and codes are utilized.

+ Reviews proposed changes in methods, manufacturing, or instrumenation (including validation, change control, and risk assessment).

+ Identifies need for and oversees consignee notifications and biological product deviation reporting.

+ Oversees management and control of the organization’s SOPs, and reviews training plans.

+ Manages QA department SOPs and User Documents, including the development and revision of content, and related training.

+ Meets with QA/QC Coordinators from operational departments on a periodic basis to collaborate on audits and oversight of QA activities.

+ Prepares reports to support quality objectives as requested.

+ Participates in departmental and organizational planning as appropriate; recommends initiatives and system changes to support KBC objectives.

+ Interacts with employees at all levels of the organization to ensure compliance and the fulfillment of quality initiatives and regulatory requirements.

+ Participates in training activities, as assigned.

+ Functions as regulatory inspection liaison or acts as QA representative or facilitator on internal committees as directed by executive leadership.

+ Participates in special projects and fulfills other responsibilities as assigned.

Work Environment: This position regularly involves the following:

+ Sit, stand, and walk for extended periods of time.

+ Fulfill basic clerical duties (typing/writing) for extended periods of time.

+ Occasionally lift/carry up to 40 pounds without assistance.

+ Frequently bend or reach to perform various job tasks.

+ Analyze complex situations and make sound decisions.

+ Adapt to changing priorities and work under pressure.

+ Occasionally travel to fulfill essential job functions.

Qualifications:

+ Minimum of a bachelor’s degree in MT/MLS/CLS with (ASCP) professional certification required with a minimum of 3 years related quality experience.

+ Minimum of three years of supervisory experience in an environment regulated by good manufacturing practices, FDA, AABB, or equivalent.

+ Advanced Microsoft Office skills with proficiency in Word, Excel, and PowerPoint, Adobe familiarity, and the ability to navigate web applications and custom systems.

+ Strong written and verbal communications, and content development skills.

+ Must be flexible, creative, adaptable, and able to effectively multitask under pressure.

+ The ability to work efficiently, and to build relationships in order to work well at all levels of the organization.

+ Ability to work flexible schedule to include occasional evenings and weekends and regular on-call rotation.

+ Valid Kentucky driver’s license with clean driving record; occasional travel to all KBC locations and to external events, required.

+ Must reside in, or be willing to relocate to, the greater Lexington/Central Kentucky area.

Benefits (All insurance coverage after 60 days):

+ Medical/Dental/Vision/Life/Disability Insurance

+ Flexible Spending Accounts/Health Savings Accounts (FSA/HSA)

+ Cancer/Accident Insurance

+ Retirement Plan with up to 10% employer contribution (after 1 year of employment)

+ Immediate PTO Accrual

+ Paid Holidays

+ Employee Assistance Program (EAP)

We are an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.