Anna-Elizabeth Rinderer Email & Phone Number

Raleigh, Nc, Us

Raleigh, Nc, Us

Raleigh, North Carolina, United States

Raleigh, North Carolina, United States

-Developed and executed Verification Test Plans (VTPs) -Executed Site Acceptance Tests (SATs) -Reviewed and redlined Piping and instrumentation Diagrams (P & IDs), performed component verification, and instrument calibration verification to ensure all design criteria are met and equipment is fit for intended use -Performed viable, non-viable, hydrocarbon, and dew point sampling for the CAP Air, oxygen, and Nitrogen Systems -Performed endotoxin (LAL), total organic carbon (TOC), conductivity, and total colony forming units (TCFU) sampling of Water for Injection (WFI) -Performed Riboflavin cleaning tests (CIP) on filter housings and solids mixing equipment -Lead Verification team for Sterile steam in place (SIP-S) efforts on media/buffer/product transfer lines -Performed Vessel temperature mapping with Kaye Validator AVS -Performed SIP temperature mapping with Lives Temperature Loggers and Biological Indicators

Charleston, South Carolina Area

• Support Validation of automated manufacturing equipment• Participate in Design of Experiments (DOE) for process development• Perform risk assessment of processes through review of PFMEA/DFMEA to determine validation sample size• Author and execute IQ/OQ/PQ of ovens using Kaye Val Probes• Author and review software validations• Review and approve validation documents per site validation strategy• Participate in root cause analysis of system failures• Utilize process capability as acceptance criteria for process validations• Document the correct installation, utility usage and intended functionality of various manufacturing equipment• Provide periodic updates of assigned validations and communicate identified roadblocks to QA manager• Identify key input and output variables of processes under validation• Served as scribe for Internal and External audits

Raleigh-Durham, North Carolina Area

•Utilized P&IDs to verify RIO and SIO (remote/solenoid input output) control panels and electrical wires as well as verify and record the identity of instruments throughout the facility.•Supported process monitoring of a commercial product by recording batch results of a commercial process. •Familiarized with the distributor control system.•Calibrated pH and DO probes.•Assisted in the set-up between the control panel and ATF systems as well as assisted in the inoculation of multiple 2L bioreactors.• Learned how to use digital caliper micrometers to measured Ferrell’s on a fermenter.• Troubleshoot a 30 L Fermenter to find a leak in the piping system and to find a miscommunication between automated valves and the DCS system.• Performed Requalification protocols of incubators, cold rooms, and fermentors using thermal mapping techniques.• Gained experience with programming, creating reports and performing post calibrations of data loggers and thermocouples.• Authored User Requirement Specifications for biochemistry analyzer, blood gas analyzer, tube sealer, chromatography skid, and viability cell analyzer. Authored general support documents including summary reports for cold room, incubator and fermentor. Authored consolidated Sampling Plans for columns, pumps ultrafiltration diafiltration and valves. Authored Requalification Protocols for Fermentors, Bioreactors and autoclaves.• Executed feed testing of glucose and methanol via a peristaltic pump to measure the accuracy of flow.• Performed riboflavin and CIP on various vessels.

Greensboro/Winston-Salem, North Carolina Area

•Aided process monitoring efforts by evaluating previous validation activities and complaints to ensure there was adherence to procedures. •Assisted in documentation of multiple monitoring reports.•Authored an Installation Qualification Report as a part of the Test Method Validation for replacing 6 leak tester devices.•Participated in the setup and utility verification of 6 leak testers in the manufacturing area. •Learned about and participated in three trials of a Gauge R&R (Repeatability and Reproducibility) process.•Developed an understanding of a heat shrink process and performed initial Design of Experiment activities to understand the relation of parameter settings to number of products processed in an effort to increase production efficiency. •Performed material investigations due to non conforming sphincterotomes, catheter bands, and cold snare handles using investigative techniques.•Utilized tools such as calipers, micrometers, RAM, pin gauges and ring gauges to collect physical data.•Developed an understanding of calibration failures and evaluated the impact on product to produce a calibration exception report.•Utilized excel to show equipment usage in order to evaluate production area improvements.•Created spaghetti diagrams to show flow of a product line in manufacturing and applied lean techniques to propose alternative arrangements in order to improve efficiency and decrease wastes.

Raleigh-Durham, North Carolina Area

• Guided attendees in safe practices to prevent problems in the future.• Performed first aid and rescue.• Prepared the pool area for a safe day.

• Lead group activities and kept swimmers attention.• Managed time and made sure the clinic was running accordingly.

Taught appropriate swim technique to inexperienced swimmers and their swim strokes.

Bachelor Of Science - Bs, Biomedical Engineering, 4.0

Activities and Societies: Alpha Delta Pi Sorority, Gamma Beta Phi National Honors society, NC State Club Swimming, University Scholars.

Diploma, 5.1 Weighted / 4.0 Unweighted

Activities and Societies: Publicity Chair of the World Cultures Club, Member of Math honors society for two years, Member of Student.

Summer Study Abroad, Engineering, 4.0