Sheila Bart Email & Phone Number

Overland Park, Kansas, United States

• Implement a risk-based clinical study audit program to enhance compliance and data integrity.
• Lead team by providing clear goals and expectations and ensuring that each member of the team. understands her/his responsibility in accordance with all SOPs and corporate policies.
• Participate in training and mentoring auditors.
• Implement internal clinical audit program which include coordinating & scheduling Internal Audits, participating in regulatory inspections and facilitating client audits.
• Ensure all internal audits are planned, scheduled, performed and results reported and documented.
• Implement quality policies and procedures.

Served as a teacher, acting as a wise and trusted guide and advisor to the mentee. Provided enriching experiences rooted in quality assurance expertise, offering personalized feedback and encouragement in various situations. Assisted the mentee in acquiring new technical knowledge and skills by guiding them through educational materials and training.

Lenexa, Kansas, United States

• Managed Product Quality oversight activities at the Lenexa, Kansas CMC (Chemistry, Manufacturing, & Control) facility and supported the Netherlands location for Investigational Product (IP) Manufacturing, Distribution.
• Strategic oversight and management of direct reports.
• Assisted in developing and implementing a new CMC manufacturing facility.
• Released Investigational Product (IP) for use in a clinical trial.
• Streamlined product release & relabeling processes.
• Partnered with cross-functional team members to ensure processes, personnel, documentation, and quality standards met regulatory expectations.

Lenexa, Kansas

• Led team by providing clear goals and expectations and ensuring that each member of the team understands her/his responsibility in accordance with all SOPs and corporate policies.
• Participated in the selection, hiring, training and mentoring of new auditors.
• Developed and implemented Quality operating (audit) plans and implemented a risk-based audit program for process and study audits.
• Implemented internal audit program which included coordinating & scheduling Internal Audits, participating in regulatory inspections and facilitating client audits.
• Ensured all internal and contracted audits were planned, scheduled, performed and results reported and documented.
• Developed & implemented quality policies and procedures. Maintained awareness of new processes and system implemented.

Lenexa, Kansas, United States

• Assisted in developing and implementing the Lenexa Bioanalytical Laboratory.
• Managed Quality Assurance program for compliance with FDA & OECD GLP regulatory standards/guidelines.
• Provided strategic and functional direction to QA team.
• Conducted process, vendor, and study audits.
• Consulted on deviations, investigations, processes, procedures, and regulations.
• Provided status and trending reports to Operational and Quality Management.

Shawnee, Kansas, United States

• Aligned Quality Management System (QMS) to comply with ISO 13485 / 9001 and 21 CFR Part 820
• Facilitated monthly meetings as Management Representative.
• Managed QMS, led and monitored continuous improvement activities for processes and products.
• Established and implemented process audit program.

Lenexa, Kansas, United States

• Monitored and evaluated effectiveness of the GLP Quality Assurance Program.
• Assisted in developing Forensic QA Program.
• Assisted in maintaining College of American Pathologist (CAP) Accreditation Program.
• Led, conducted & reported quality audits.

cGMP Requirements & Quality/Customer Focus

Analytical Techniques & Lab Trainer

Lincoln, Nebraska Metropolitan Area

Analytical Techniques & Good Laboratory Practices (GLP) regulations

Master Of Forensic Science, Biology/Chemistry

General Studies

Bachelor Of Science (B.S.), Biology