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; management of validation resources; validation services process consultantReceived CEO Performance Excellence Award January 2015; The CEO Performance Excellence Award is a prominent award that was established to recognize employees who deliver world class quality and customer service, make substantial contributions to the company in excellent delivery of a key project, or who develop innovative ideas to improve the way we do business.

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.• Supervised the daily activities of other validation analysts, or associate validation analysts.• Directed validation efforts and provides technical guidance on more complex issues.• Managed assignments to meet deadlines and produce high quality deliverables.• Remained familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs/WPDs.• Participated in departmental and corporate process initiatives.• Cross trained and mentored validation analysts on systems of expertise.• Trained personnel resourced to validate software releases, including internal testers, contractors and temporary employees.• Prepared for and represented department within relevant system related client / audit forums.

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. • Updated current WPD’s and initiated new WPD’s at corporate level. • Played an integral role in preparing plant for ISO 2000 certification.