Quality Assurance Director

SUMMARY:

The QA Director is responsible for developing, implementing, and monitoring a sound Quality Assurance Program for Shepeard Community Blood Center (SCBC). The primary responsibility is to ensure that the organization meets all regulatory requirements for collecting, manufacturing, and distributing blood products.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (may include, but not limited to)

• Serves as the subject matter expert in compliance with federal and state laws and regulations and any applicable accreditation standards.
• Supports Shepeard’s operational leaders by providing guidance and interpretation of regulations and standards.
• Uses knowledge and expertise of the regulatory environment to solve problems and proactively advance business goals in the areas of safety, collections, finance, and efficiency.

• In collaboration with senior leadership, oversees the review of SOPs, validations, maintenance, storage, and other processes.
• Ensures the timely and proper reporting of activities as required by law including but not limited to product recalls, annual reports, & licensure submission.

• Leads the process of implementing, maintaining, and refining a document management system.
• Development of procedures to ensure the investigation, evaluation, correction, follow-up, and review of all reported errors and non-conformities.
• In collaboration with department directors, review and provide oversight of training/competency programs.

• Review equipment qualification, validation, maintenance, and calibration procedures.

• Embodies a culture of stewardship for the donations received by the organization and their life-altering impacts.

• Oversees record review.
• Coordinates site inspections (FDA, AABB, etc.), monitors follow-up, and provides corrective action(s).
• Checks that all staff members have yearly reviews and updates on new procedures.
• Assists in the training and instruction of SCBC Staff in the area of compliance and Quality Assurance.
• Works with Shepeard leadership team to complete its strategic plan and advance the mission and vision of the organization.

• Meets Key Performance Indicators (KPIs) assigned to this position.

• Follows SCBC and departmental policies, procedures, and guidelines with regard to employees, customers, and property.

SCOPE OF AUTHORITY/REPORTING:

The employee is required to perform assigned daily routines on a timely basis. The employee is expected to work with other department directors as a team in order to provide the best quality service to donors.

QUALIFICATIONS:

Education

Bachelor's degree required.

Master's degree in the field of medical technology is preferred.

SBB is highly preferred.

Experience

• Six (6) years blood bank or Quality Assurance experience.

Knowledge/Skills/Abilities

• Must have, or acquire familiarity with, FDA/AABB regulations and compliances and be familiar with OSHA and CLIA requirements. Serves as a resource to SCBC employees in these areas.
• Must have ability to work independently. Maintains good organization of records. Has solid verbal and written communication skills. Works cooperatively with others and maintains good interpersonal relations and leadership in directing the QA Department.

PHYSICAL SKILLS/REQUIREMENTS:

Employee will be regularly required to stand, walk, reach, stoop, kneel, bend, twist, and push/pull.

WORKING CONDITIONS:

High-risk exposure to blood-borne pathogens. Works in an office with adequate light, climate control and moderate level of noise. Occasionally, works on bloodmobiles and mobile sites where conditions vary.

DISCLAIMER:

This job description is not intended to be all-inclusive. The employee will also perform other reasonable related business duties as assigned by the supervisor or other management.

Management reserves the right to change job responsibilities, duties and hours as needs prevail. This document is for management communication only and is not intended to imply a contract of employment.