Open to opportunities

Alicia Sonne

@aliciasonne

Message

Experienced Healthcare Compliance Supervisor with a focus on quality management.

United States

Message

What I'm looking for

I am looking for a role that values quality and compliance, offers opportunities for leadership, and fosters professional growth.

I am a dedicated Healthcare Compliance Supervisor with extensive experience in managing quality management systems within large-scale 3PL warehouses. My career spans over several years, during which I have successfully led multidisciplinary investigations into nonconformances, ensuring compliance with regulatory standards and implementing effective corrective actions. My role involves hosting audits for clients and regulatory agencies, where I present key performance indicators and metrics that drive continuous improvement.

Throughout my career, I have developed a strong proficiency in utilizing tools such as SmartSolve and Microsoft Office, and I am well-versed in ISO 9001, ISO 13485, and 21 CFR compliance. My leadership skills have enabled me to build and develop teams of quality specialists, fostering an environment of collaboration and employee development. I take pride in my ability to identify risks and implement mitigation strategies that enhance operational efficiency and compliance.

Experience

Work history, roles, and key accomplishments

Current

Healthcare Compliance Supervisor

Current

UPS-SCS

Nov 2018 - Present (6 years 7 months)

Managed all aspects of the Quality Management System for a 500,000 sq ft 3PL warehouse with 15 active accounts, including cold chain and controlled substances. Led multidisciplinary investigations into nonconformances from root cause analysis to implementation of corrective/preventative actions.

Quality Management Systems Controlled Substances Root Cause Analysis ISO 9001 ISO 13485 Microsoft Office

Quality Assurance Supervisor

Arvato Bertlesman

Mar 2018 - Present (7 years 3 months)

Managed all aspects of the Quality Management System for a 3PL warehouse with 5 active accounts distributing electronics, gaming systems, and cell phones. Updated all WI/SOPs and brought the facility into ISO Compliance to prepare for the ISO 9001 recertification audit.

Quality Management Systems ISO 9001 Multidisciplinary Investigations

Lead of Quality and Regulatory Affairs

Owens and Minor

Jul 2014 - Present (10 years 11 months)

Led all VAS cage activities, including inspection/release of incoming material along with orders for color coding, etching, kitting, packaging, and labeling. Managed the training program to ensure cGMP compliance.

VAS Cage Activities Kitting Packaging

Education

Degrees, certifications, and relevant coursework

Spalding University

Bachelor of Science, Nursing

Activities and societies: Leadership, problem solving, and employee development. Risk identification/mitigation and process mapping. Proficient at using SmartSolve and Microsoft Office. Well versed in ISO 9001, ISO 13485, 21 CFR compliance and 3PL licensing requirements. Experienced in the use of calipers, optical comparator, and hardness tester.

Managed all aspects of the Quality Management System for a 500,000 sq ft 3PL warehouse with 15 active accounts including cold chain, controlled substances, generic pharmaceutical, biologics, medical devices and animal health pharmaceutical and medical devices. Led multidisciplinary investigations into actual and potential nonconformances from investigation/root cause analysis to implementation of