Full service training and consulting firm. Implementing creative solutions along with customized strategic goals that delivered the desired outcome. Extensive experience in process/project management that included developing and tracking projects using various metrics

Complaint handling, quality assurance, interfacing with field and medical staff. Investigate and process complaints from global sources. Report quality metrics to management.

Courses taught: Strategic Management, Regulatory Compliance and Business Management. Student advising, course development and revision.

Perform investigations, deviations, CAPAs and revise documents such as SOPs. Work Instructions, etc.

• Collaborated with the QA and QC departments to bring CAPAs and document revisions to closure. • Conducted deviation investigations, root cause analysis, product impact analysis and closure.• Managed projects from inception through implementation and closure• Maintain department training records, LMS database and Microsoft Excel reporting and revise/generate SOPs and manuals • Report quality metrics to managementHealthcare/pharmaceutical industry

Taught management and HR courses. Student advising, course development and revision.

• Conducted deviation and product impact investigations, root cause analysis, and closure.• Review and approve batch records, labeling, device records (DHR/DMR)• Reviewed and approved Quality Assurance documentation: SOPs, complaint files, audit performed floor audits.• Responsible for managing direct and indirect reports. • Lead Internal Auditor certified (cGMP). • Accountable for documentation, quality, regulatory activities, customer complaint investigation, internal and external audits, process validation. • Managed projects from inception through implementation and closure.• Trained new personnel on the CAPA and audit process• Report quality metrics to management

• Managed inter-departmental projects, including quality, manufacturing and regulatory compliance events. • Reviewed and approved Quality Assurance documentation: SOPs, complaint files, audit reports, batch records and CAPAs. • Shared management responsibilities for an average of 15 Subject Matter Experts with responsibility for evaluating, scheduling and training.• Conducted all training for incoming employees, coordinating with all departments to assure compliance with regional, national and global regulatory requirements (such as QSR). • Lead Internal Auditor (cGMP)• The Buffalo Grove site was recognized as the “Best Site” for compliance, globally corporate wide for the years 2006-2008. • Managed QA projects from inception through implementation and closure• Report quality metrics to management

Train field service engineers and external clients on the SMT productions equipment. Speedline screen printers operation, maintenance, repair and calibration.

AD3 and Certified Technical Trainer