Jennifer Shultz Email & Phone Number

United States

Austin, Texas Metropolitan Area

On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD. Together, Thermo Fisher and PPD share the pursuit of a common goal: to enable customers to make the world healthier by accelerating the development of new medicines.

Austin, Texas, United States

Austin, Texas Area

Austin, Texas Area

Manage IT Business Continuity Plan; support management of IT standard operating procedures (SOP), working practice documents (WPD) and policies; change management system administration; audit training readiness, IT SOP/WPD training; IT representation in client and regulatory audits; support and maintenance of departmental workspace for internal websites.

Austin, Texas Area

• Served as validation support for new releases and modifications to applications.
• Prepared risk based Performance Qualification (PQ) test assessments, validation plans, test cases and validation summary reports and executes test cases.
• Met with project teams on a regular basis to ensure effective communication and accuracy in testing.
• Ensured test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.
• Created, updated and managed data within the testing environment, sufficient to accurately test software functionality.
• Worked with IT project manager to address any PQ related issues arising from audits.

Austin, Texas Area

Austin, Texas Area

Austin, Texas Area

Austin, Texas Area

• Created and maintained changes to study profiles and flowcharts in internally developed clinical trial management system for Phase I Clinic.
• Created and maintained electronic Case Report Forms (eCRF’s) for specific protocols in system.
• Analyzed complex data to determine eCRF feasibility.
• Assisted in training team members in the flowchart process.
• Worked closely with IT for system enhancements.
• Provided information on weekly basis to teams of study specific timelines for creation, quality check and conversion of flowcharts.

Austin, Texas Area

• Audited study files for offsite storage preparation.
• Conducted document reviews to ensure accuracy, consistency and integrity of data/information.
• Assisted in sponsor and FDA audits

Austin, Texas Area

Same as Study Logistics Specialist (position was re-titled).

Austin, Texas Area

• Conducted research studies in drug development Phase I.
• Maintained source documentation collected during study conduction.
• Assisted fellow team members in recruitment, conduction and data transcription.
• Communicated study updates to supervisor, project managers, and investigators.
• Assisted in final close out of study prior to archive.
• Interacted with project sponsors when needed.

Austin, Texas Area

• Provided mentoring to other Pharmacy Technicians and assist in on-the-job technician training.
• Maintained good customer service, including phone support, question and answer.
• Prescription management: Inputting prescriptions, insurance claims, answering general customer questions on medications, label prescriptions, counting pills for prescriptions.
• Office management: Warehouse returns, wholesaler returns, ordering replacement stock, and process worker's compensation claims.

Round Rock, TX

• Maintained the plant machinery maintenance and calibration records.
• Performed regular audits of plant for SOP and WPD conformance.
• Wrote and maintained Non-Conformance reports on audit findings.
• Maintained various client data and sent client monthly reports.
• Prepared and led client presentations of overall plant performance.
• Performed weekly bacterial water testing to ensure closed sterile system.