Quality Assurance Ipt Coordinator Quality Laboratory Intern resume example

To obtain employment as an Associate Scientist within a progressive pharmaceutical company that will allow me to utilize my skills, knowledge, and teamwork experience in regulatory operations. Determined to build on process knowledge while continuing to learn, & work hard; motivated to do whatever it takes to get the job done efficiently and properly. These things include paying attention to detail, organizational skills, interpersonal skills, critical thinking and troubleshooting skills to obtain day to day results. I will also use good communication skills to resolve any issues that may occur; able to maintain a cool demeanor during heated or challenging circumstances. Very eager to learn and work on projects as necessary. I am able to perform GLP, CGMP, QC, microbiology, and molecular biology assays. I am proficient in my understanding of Phase 1-3 clinical trials. I am also a seasoned nurse able to work with doctors and patients well. I possess a great understanding and skill of medical terminology, monitoring of side effects of medications, documentation in charts, QA and QI assessments, etc. I also have an excellent understanding of pathophysiology and the disease process. I am willing to work overtime if needed and weekends. RTP, NC Contract Manufacturing Science Associate/ Manufacturing Associate Proficient in operating and understanding of cGMP, GMP , GLP compliance with FDA, traceability, area safety, and documentation in real time Knowledge and experience with Class A, Class B , Class C classified areas (currently working in Class B classified area)/ experience gowning in areas Daily to weekly Bioburden Testing, Endotoxin Testing,TOC, Conductivity, Validation Test, PH, Osmoality, Aseptic Testing and Technique , Spectrophotometry, Dilutions, Growth Promotion Testing of Product and Equipment Evaluation of batch records prior to sending to QA and QC Familiar with Lean Six Sigma Experience training new employees on operations of process, CGMp, and equipment in area/ safety protocol Ability to execute manufacturing processes, while utilizing SOPs, batch records, and assigned equipment(ex. Delta V) Execute review of SLRs, batch records, and other important documentation Extensive work on process unit operations(pre/post downstream processes to include making buffers, autoclaving, Column Chromatography, building tank, instrumentation, troubleshooting, validation protocols, and hold studies, sampling/testing during process, serial dilutions, pipetting, aseptic technique, spectrophotometry, environmental monitoring during bottling, Able to use Excel, Lims, PowerPoint, Delta V Maintaining and ordering inventory/ weighing and dispensing components (worked in dispensary a little)