• Managed the validation life cycle and write deliverables (URS, audit trail review work instructions, operational SOPs) for qualification of GMP assets with a risk-based approach• Liaised and consulted with QA and IT in drafting validation documents • Prepared and organized documentation to assist in audits from regulatory agencies such as FDA and TGA• Drafted and reviewed change controls on Trackwise for CAPAs, deviations, and new assets• Trained and mentored new validation engineers in company processes and validation

• Supported the entire equipment qualification lifecycle (Design, Installation, Operation, Performance) for GMP • Completed GMP Computer System Validations (CSV) using a computerized system lifecycle approach with an emphasis on data integrity and electronic records and electronic signatures • Authored, edited, and implemented QA approved validation protocols, SOPs, Quality Project Plans, and risk/impact assessments necessary for GMP activities and compliance• Ensured preventative maintenance, calibration, and repairs were completed promptly using SAP R/3 along with decommissioning instruments when ready to retire• Managed vendor activities as well as negotiate new contracts for services and instruments as needed• Initiate and review change record data (discrepancies) and implement corrective actions where applicable for operations• Completed periodic reviews for qualified systems in accordance to set review intervals• Backed the conversion of an entire lab from R&D state to GMP audit-ready state to increase capacity for operations• Participated in regulatory audits (internal and external) and assist with CAPA implementation when necessary• Assist in overall operations for department including: working with vendors, troubleshooting equipment, and coordinating with interdepartmental resources.

• Performed and documented testing of clinical final product, tox, and stability samples under GMP and GDP guidelines• Supported lab GMP, EHS, and 5S operation and compliance with equipment verification, maintenance, and general housekeeping• Incorporated ELN (electronic lab notebook) into processes such as pipet calibration logs and validation sample binders• Maintained and ordered media prep reagents, performed Yokogawa checks, and created GMP logbooks to sustain lab

In addition to my responsibilities as a Process Development Intern, I assisted in manufacture, shipping, and inspecting of the SAMBA HIV-1 test (based on a nucleic acid assay). Participated in the manufacturing of large batches of reagents under current Good Manufacturing Practices (cGMP) and Good Laboratory Practice (GLP). This position required me to work in a team environment coordinating with many others to meet shipping deadlines, keep accurate records, and complete various manufacturing tasks.

Carefully maintained a safe and clean lab environment for students to complete experiments in. Assisted students by setting up experiments, answering questions, and operating various instruments (HPLC, GC, IR).This position required a cohesive knowledge of general and organic chemistry principles and it allowed me to hone them by applying them to different student's situations.

In the surgery information department, I communicated the status of patients surgeries to families as well as provided room numbers for inpatients.The emergency department required me to organize supplies for staff and provide patients with clean beds and beverages. This volunteer position enhanced my interpersonal skills in addition to enhancing my appreciation for philanthropy.

Successfully manufactured and shipped over 10,000 Chlamydia and Hepatitis Rapid Tests for use in foreign countries.I was able to develop a skill of paying attention to minute details not only inspecting components but also in controlled documentation (SOP). This position required me to be extremely responsible and meticulous as the products which we sent had an impact on other people's lives.