Sheila Bart Email & Phone Number

Kansas City, Mo, Us

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. • Work closely with internal stakeholders to assist in the management of overall quality, compliance, auditing, and regulatory authority inspection activities to ensure compliance of operations with corporate policies, industry standards, and quality improvement programs.• Interpret & consult on regulations and guidances.• Facilitate quality investigations and CAPAs.• Provide status and trending reports to Quality Management.• Conduct Clinical (GCP) Audits.

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 opportunities.

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, Storage, Destruction and Testing.• 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.• Resourced, facilitated and/or supported client audits.• Developed a risk-based GMP self inspection program.• Supported FDA inspection of the Clinical (GCP) Phase 1 Unit. • Collaborated with internal stakeholders on quality related issues, investigations, and regulations. • Engaged with business owners on audit findings and to monitor timelines and track progress. • Conducted self-inspections, vendor audits and study audits. • Reviewed & approved various documentation: certificate of analysis (CoA), change controls, deviations, out of specifications, CAPAs, risk assessments, master & executed batch records, specifications, validation & stability protocols/reports, quality agreements, procedures, equipment validations, and facility & personnel qualifications reports.• Developed Supplier Questionnaire to ensure all raw materials, excipients, Active Pharmaceutical Ingredient (API), and primary packaging components were compliant with Nitrosamine, Melamine, and BSE/TSE requirements.

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.• Utilized tools and methodologies to increase efficiencies in Global Quality processes.• Worked closely with internal stakeholders to assist in the management of overall quality, compliance, auditing, and regulatory authority inspection activities to ensure compliance of operations with corporate policies, industry standards, and quality improvement programs.• Engaged with project team to recommend and implement steps to mitigate identified risks.• Interpreted & consulted on regulations and guidances.• Provided status and trending reports to Operational and Global Quality Management.• Supported Clinical (GCP) QA Audit Activities.

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.• Supported Clinical (GCP) QA Audit Activities.

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