Manager of Quality Assurance - Augusta, United States - Walter L. Shepeard Community Blood Center

Description

Job Description

Manger of Quality Assurance

About Us

At Shepeard Community Blood Center, we're committed to saving lives through safe and high-quality blood products. As the Manager of Quality Assurance, you'll play a crucial role in ensuring our processes meet the highest standards.

Responsibilities

1. Regulatory Compliance Champion

• Collaborate with the Director of Quality Assurance to maintain compliance with FDA and AABB regulations.
• Stay informed about changes in regulations and industry standards.
• Investigate and respond to biological product deviation reports.
• Be our frontline liaison during inspections.

2. Quality Programs Steward

• Drive our quality programs to maintain licensure and accreditation.
• Conduct internal and external audits.
• Manage supplier qualifications, change control, and deviation management.
• Ensure meticulous document control and record retention.

3. SOP Oversight and Enhancement

• Review and enhance our Standard Operating Procedures (SOPs).
• Champion document and change control practices.
• Implement improvements across the organization.

4. Training and Competency Advocate

• Maintain training and competency standards for all employees.
• Coordinate center-wide training initiatives.
• Be the go-to resource for staff training and competency.
• Support our "Train the Trainer" program.

5. Audits and Continuous Improvement

• Develop and implement robust procedures for internal audits.
• Analyze audit findings and collaborate on corrective action plans.
• Engage with FDA inspectors, AABB assessors, and plasma vendor representatives.

6. Excellent Communication Skills

• Understand team responsibilities and step in when needed.
• Foster positive communication across departments.
• Attend relevant meetings and encourage staff to seek support.
• Boost morale through recognition and constructive feedback.

7. Align with Our Values

• Uphold SCBC values, quality objectives, and customer service standards.
• Promote our strategic direction to all employees.

Qualifications

• Three to five years experience in a blood bank or transfusion service preferred.
• Management/Supervisory experience preferred.
• Must have, or acquire, familiarity with FDA/AABB Regulations/Standards and be familiar with OSHA and CLIA requirements.
• Excellent conceptual, communication, and analytical skills.
• Strong interactive abilities for effective collaboration.

General Knowledge and Skill Abilities

• Knowledgeable Biologics Expert: Demonstrates a deep understanding of regulations and standards related to biologics, including blood products, donor suitability, and infectious disease testing. Maintains up-to-date knowledge of industry best practices and organizational procedures.
• Effective Communicator: Possesses strong written and verbal communication skills, fostering collaboration with colleagues and maintaining positive relationships with leadership and fellow Shepeard Community Blood Center team members.
• Regulatory Navigator: Skillfully interprets complex guidelines, laws, and statutes, ensuring compliance with cGMP, CLIA regulations, OSHA rules, and industry standards. Makes quality-focused decisions to drive excellence.
• Confidentiality Champion: Safeguards sensitive information, demonstrating impeccable discretion.
• Organizational Dynamo: Maintains order, ensuring efficient processes and effective problem-solving.

Licenses and certifications:

• MT or MLT with Appropriate Certification
• Bachelor's degree in laboratory science preferred.

DISCLAIMER:

This job description is not exhaustive. The employee may be required to undertake other relevant and reasonable business duties as directed by their manager.

Management retains the discretion to alter job responsibilities, duties, and working hours according to business requirements. This document serves solely for managerial communication and does not constitute an employment contract.

All candidates chosen for employment are required to complete a pre-employment drug test.

Join us in making a difference—your expertise will save lives