Post Job Free

Resume

Sign in

Regulatory Compliance Quality Manager

Location:
Sevierville, TN
Salary:
Negotiable
Posted:
December 30, 2023

Contact this candidate

Resume:

SAMANTHA J. SCOTT

*** *** **** ***

Seymour, Tennessee 37865

205-***-**** ad2bri@r.postjobfree.com

PROFILE SUMMARY

Quality Manager with proven leadership ability and comprehensive knowledge of regulatory and administrative processes committed to quality service delivery and excellent organizational outcomes. CORE COMPETENCIES

• Significant knowledge of center operations, clinical procedures, regulatory compliance, and phlebotomy and plasma processes.

• Enforce regulatory compliance consistent with best practices and policies and procedures maintaining quality standards.

• Effectively manage personnel ensuring completed competencies, effective training, and positive engagement.

• Excellent interpersonal, organizational, leadership, clinical, technical, and communication skills and independent decision-making ability with great attention to detail. CERTIFICATIONS

• CPR Certified

PROFESSIONAL EXPERIENCE

Adma, Maryville, Tennessee

Center Quality Manager, September 2022

• Manage administrative and quality processes in support of center activities adhering to Standard Operating Procedures (SOPs) and applicable laws.

• Enforce regulatory requirements and develop and implement policies and procedures consistent with operational guidelines and report any deviations from regulatory compliance as required.

• Initiate and review audits, perform observations, and conduct record reviews as well as gather and compile center data and information from records or direct observation.

• Maintain appropriate documentation and manage quality initiatives and quality programs and ensure preventative actions and appropriate investigations are completed to

• Effectively manage and train personnel and conduct performance evaluations providing feedback regarding employee performance while promoting an environment conducive to positive engagement and outcomes.

• Ensure appropriate labeling of products and verify that supplies and materials meet quality regulations as well authorize the release of final products consistent with quality standards. Parachute Plasma, Paris, Texas

Assistant Manager, November 2020 – August 2022

• Managed clinical and administrative operations maintaining optimal efficiency and performed human resource management functions including training and performance management.

• Served as a subject matter expert regarding medical screening, phlebotomy, and plasma processing functions.

• Effectively resolved inquiries and issues adhering to policies and procedures as well as maintained regulatory compliance enforcing policies and procedures and standards of operations.

• Managed documentation processes associated with business operations and center activities and ensured quality services in a safe environment providing quality customer service. Grifol’s, Birmingham, Alabama

Operation Supervisor, April 2018 – November 2020

• Managed all aspects of clinical operations ensuring efficient donor flow and optimal productivity and enforced center policies and procedures and mandated regulatory compliance.

• Performed administrative and clinical processes including plasma collection and records management processes.

2

• Generated reports providing details regarding business operations and center activities and performed human resource functions including employee supervision, training, and performance management.

• Developed an excellent rapport with donors promoting quality service, donor retention, and excellent customer service, and communicated with team members regarding documentation and quality.

• Performed financial management functions associated with center donor funds ensuring accuracy and monitored and equipment in an effort to maintain continuous operations. McDonald’s, Hueytown, Alabama

Shift Manager, April 2017 – April 2018

• Successfully manage subordinate employees promoting an environment conducive for positive teamwork and employee engagement.

• Facilitated employee supervision, performance management, staffing, and development and training.

• Managed store opening and closing procedures as well as maintained excellent customer service ensuring all issues are resolved in a timely manner.

• Monitored inventory ensuring the availability of all items and products and implemented food safety processes.

• Participated in marketing initiatives to promote sales and developed customer loyalty resulting in enhanced business operations.

• Conducted routine maintenance on equipment for optimal performance and to ensure safety for employees and continuous operations.

INTERNSHIP

LabCorp, Anniston, Alabama

August 2017 – April 2018

• Obtained specimens from various age groups in accordance with policies and procedures and prepared samples in a safe and skillful manner.

• Properly disposed of blood or other biohazard fluids in accordance with applicable laws, standards, and policies.

• Adhered to all regulatory and safety standards including needle usage and disposal and maintained confidentiality in accordance with HIPAA and all facility policies and procedures. EDUCATION

Jeff State Community College, Birmingham, Alabama, Phlebotomy Program, December 2017

Virginia College, Birmingham, Alabama

Associate of Applied Science Degree, June 2003

COMMUNITY INVOLVEMENT

Jessie’s Place, Birmingham, Alabama (Volunteer)

Habitat for Humanity, Birmingham, Alabama (Volunteer)



Contact this candidate