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Quality Assurance Specialist I

Kentucky Blood Center Inc

This is a Full-time position in lexington, ky posted November 25, 2021.

Now offering a $500 Sign-On Bonus (after 90-days)

$100 COVID-19 Vaccine Incentive

Hours: Tuesday through Saturday, with day hours to be determined.

The Quality Assurance Specialist I is responsible for performing daily donor questionnaire reviews, performing audits (quality systems and focused). The role also maintains the occurrence management program, and prepares reports related to nonconforming products. Reports to the Director of Quality Assurance.

Responsibilities

  • Maintains the Occurrence Management program in accordance with SOP 20-70-001.
  • Performs consignee notifications when indicated as assigned.
  • Prepares biological product deviation reports as assigned.
  • Performs internal audits as assigned.
  • Assists with facilitating external audits.
  • Performs daily audit of donor questionnaires prior to labeling to ensure that units meet suitability requirements.
  • Participates in product disposition determination based on current regulations, KBC policy, and coordination with KBC Medical Directors as needed.
  • Prepares reports as assigned.
  • Develops and revises departmental SOPs as assigned.
  • Identifies and quarantines potentially nonconforming products during audits.
  • Initiates occurrence reports for quality compromising occurrences discovered during donor record audit.
  • Serves as member of Quality Improvement Committee.

This position requires that you:

  • Work independently, without constant supervision.
  • Be conscientious and dependable.
  • Maintain accurate and legible records.
  • Comply with all applicable safety rules and policies and be willing to report actual and potential safety violations to the appropriate supervisor or manager.
  • Practice universal precautions and infection control measures.
  • Maintain and respect confidential information.
  • Abide by all policies outlined in the Employee Handbook.
  • Practice good customer service with both internal and external customers.
  • Demonstrate a commitment to KBC’s Quality Plan.
  • Demonstrate a commitment to KBC’s Mission Statement.

Minimum Requirements

  • High school or equivalent, required.
  • Related auditing experience in a quality control/quality assurance function, or a similar role in a regulated medical/health care environment, highly preferred.
  • Ability to multitask and remain organized and flexible under pressure.
  • MS Office and Adobe proficiency with the ability to navigate web applications and custom systems; data entry/keyboarding experience, required.
  • Flexible schedule availability, including regular weekends, and some evenings.

Benefits (All insurance coverage after 60 days):

  • Medical/Dental/Vision/Life/Disability Insurance
  • Flexible Spending Accounts/Health Savings Accounts
  • Cancer Insurance/Accident Insurance
  • Retirement Plan with up to 10% employer contribution (1 year of employment)
  • Immediate PTO Accrual
  • Paid Holidays
  • Employee Assistance Program (EAP)

PI153581336