This document is a resume for Meghan Carty Shadwell, who has over 12 years of experience in pharmaceutical quality assurance and compliance training. She currently works as a QA Training Coordinator for Shionogi Inc., where her responsibilities include conducting training needs assessments, developing training programs, maintaining a learning management system, and ensuring training compliance. Prior to her current role, she held similar training positions at several pharmaceutical companies.

1. Meghan Carty Shadwell
17 Edgemont Road
West Orange, NJ
meghanshadwell@gmail.com 201-452-2311
Summary: Pharmaceutical professional with 12+ years of experience in Quality Assurance/
Compliance Training. Provide training needs analysis, develop and conduct interactive,
engaging training programs, provide training evaluations, track all training and determine gap
analysis, ensure over-all compliance and maintain a state of “audit readiness”.
Specialties: Training, Documentation, Auditing; LMS; FDA regulations; current Good
Manufacturing Practices; Standard Operating Procedures; Aseptic Technique;OSHA
regulations; Adult Learning Principles
Proficient in E-Learning/Articulate (Inc. Flash/Video/Web
Objects/HTML5)/Instructional Design/LMS/Web-ex/Microsoft
Word/Excel/PowerPoint/Outlook
*Certified in E-Learning and Instructional Design
Experience:
Shionogi Inc. (Pharmaceutical)
QA Training Coordinator May 2014-present
 Conduct Training Needs Assessments.
 Develop, facilitate and track cGMP training.
 Procedural documentation roll-out and tracking.
 Member of LMS core team.
 Assisted with all aspects of rolling out LMS to organization.
 Maintain and Administer Learning Management System.
 Assist with internal and external audit requests.
 Ensure training compliance in all areas of the organization.
 Resolve and respond to training issues and questions.
 Audit individual departments for training and conduct gap analysis.
 Author training SOPs.
 Conduct New Hire training sessions for all new hires.
 Maintain state of “audit readiness”.
Full time Homemaker/PTA RecordingSecretary/ August2005-February 2014
Community Volunteer
Hoffmann-La Roche Pharmaceutical
Compliance and Technical Trainer February 2003-August 2005
 Conducted Training Needs Assessments.
 Developed and facilitated all QA cGMP training.
 Developed and facilitated OSHA training programs.
 Conducted "Train the Trainer", New Hire Orientation and Aseptic Technique training
programs.
 Provided training of Standard Operating Procedures.
 Kept documentation through administration of Learning Management System.

2.  Generated training compliance reports for audit purposes.
 Assisted with formulation of training policies.
 Main point of contact for all internal and external audits
 Constructed and developed training materials, aids, manuals and tests.
PAR Pharmaceutical
Training Administrator March 1999-February 2003
 Developed company-wide corporate training program “from the ground- up”.
 Conducted Training Needs Assessments.
 Developed and facilitated training of all company-wide cGMP training (specifically
Manufacturing/Packaging and QC Lab)
 Conducted New Hire Orientation training.
 Developed and facilitated OSHA training (specifically for Engineering and Warehouse).
 Provided training of Standard Operating Procedures.
 Kept documentation through administration of Learning Management System.
 Generated training compliance reports for audit purposes.
 Assisted with formulation of training policies.
 Main point of contact for all internal and external audits.
 Constructed and developed training materials, aids, manuals and tests.
 Audited individual departments for training and conducted gap analysis.
Almedica Services (Pharmaceutical Packaging)
Training Administrator November 1997-March 1999
 Developed company-wide corporate training program “from the ground-up”.
 Conducted Training Needs Assessments.
 Developed and facilitated training of all company-wide cGMP training and “Train the
Trainer” programs.
 Provided training of Standard Operating Procedures.
 Prepared reports and testing procedures for evaluation.
 Assisted with formulation of training policies.
 Main point of contact for all internal and external audits.
 Audited individual departments for training and conducted gap analysis.
Office Manager November 1994-November 1997
 Managed team of three employees
 Oversaw all office related activities (i.e. reception, administrative, maintenance of batch
records, documentation, etc.)
Education: B/A English, Susquehanna University
Professional Organizations: Association for Training and Development
Certifications: E-Learning and Instructional Design