Jennifer Willhide Email & Phone Number

Gaithersburg, Maryland, US

Gaithersburg, Maryland, US

Gaithersburg, Maryland, US

Gaithersburg, Maryland, US

Gaithersburg, Maryland, US

• Supervise department staff including hiring, training, project assignments and evaluations to ensure top performance, professional development, continuity and quality.
• Establish and maintain a document control system for Quality System documents and associated documents used and generated on the site that are compliant with regulations to support business operations.
• Act as eDOCs Site Administrator
• Develop and maintain employee training curricula.
• Develop content and format of training materials for the good manufacturing, laboratory, and clinical practices (GxP) training program.
• Execute training program for new and existing employees.

Gaithersburg, Maryland, US

• Supervised 21 CFR Part 11 validation including drafting Master Validation Plan, Installation, Operation and Performance Qualification Protocols, and Master Validation Summary, executed testing and maintained change.
• Developed and maintained work process flows for routing and approval of regulated documents
• Acted as Site and System Administrator including troubleshooting, user assistance and software manufacturer liaison
• Maintained GXP Quality Systems including, CAPA, Change Control, Deviation/Investigations, Regulated Information Technology Environment Change Control, and Label Content Management, among others.
• Provided complex technical support and act as point of contact for the NextDocs Support
• Supervised department staff including hiring, training, project assignments and evaluations to ensure top performance, professional development, continuity and quality.

• Supervised 21 CFR Part 11 validation including drafting Master Validation Plan, Installation, Operation and Performance Qualification Protocols, and Master Validation Summary, executed testing and maintained change.
• Developed and maintained work process flows for routing and approval of regulated documents
• Acted as Site and System Administrator including troubleshooting, user assistance and software manufacturer liaison
• Provided complex technical support and act as point of contact for the NextDocs Support
• Supervised department staff including hiring, training, project assignments and evaluations to ensure top performance, professional development, continuity and quality.

• Managed Electronic Document Management System (EDMS) including training program, SOPs, GXP documentation and business documentation
• Managed Training Grant applications and reimbursement
• Reviewed current quality processes/systems; Established systems to meet industry standards and total quality management aligned with company goals
• Maintained Internal audit program including, scheduling, performing and closing audits.
• Maintained GXP Quality Systems including, CAPA, Change Control, Deviation/Investigations, Regulated Information Technology Environment Change Control and Label Content Management, among others

• Coordinated FDA compliant change control management system
• Managed product investigation and deviation system to meet GMP requirements
• Conducted audits of internal processes and instituted Corrective Actions/Preventative Action plans (CAPAs)
• Managed DVC Training Department and served as Training Coordinator
• Assisted American Red Cross with Quality, Training and Problem Management including: -Designing training program to meet FDA requirements including authoring SOPs, workflows and database design. -Serving as the Level 1.

• Managed development and compliance of multiple departments with varied training needs
• Developed curriculum program to accurately assess and assign training throughout the company
• Supervised Learning Management System (LMS) and assured data integrity through annual audits of training files
• Developed and conducted various trainings including New Employee Orientation and Introduction to GxP for all new employees
• Managed relationships with local and state offices to acquire training grants and reimburse costs
• Wrote departmental Standard Operating Procedures, Manuals, Policies and Position Descriptions