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. • Ensure continuous improvement in the training program. • Participate in other quality systems activities such as internal and vendor audits, corrective and preventive actions, inspection preparation and change control as required. • Act as EPDG CSV Subject Matter Expert for validation of computer systems• Manage Change Control, CAPA and Deviations for the RSDL product.

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 control on an Electronic Document Management System•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.•Maintained Internal audit program to confirm DVC processes ensure product safety, quality, efficacy •Reviewed current quality processes/systems; Established systems to meet industry standards and total quality management aligned with company goals•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 control on an Electronic Document Management System•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 Problem Manager on the ARC Account. -Conducting independent review and GAP Analysis of the System 10 Problem Management System. -Preforming CSC process audits of ARC procedures

•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