Cristina L.
About Cristina L.
Cristina L. is a QC Analyst III at Alkermes in Wilmington, Ohio, with extensive experience in GMP investigations and compliance with FDA, cGLP, and cGMP regulations.
Title
Cristina L. currently holds the position of QC Analyst III at Alkermes, based in Wilmington, Ohio, United States.
Company
Cristina is currently working at Alkermes, where she takes on the role of QC Analyst III. Alkermes is a company that focuses on the research, development, and commercialization of pharmaceutical products. In her role, Cristina supports quality control processes particularly in adherence to industry standards and regulatory requirements.
Background
Cristina L. brings a wealth of experience from previous roles to Alkermes. She worked as a Chemist II at Wockhardt USA in the Greater Chicago Area from 2016 to 2020. Prior to that, she served as an Analytical Chemist I at SGS in Lincolnshire, IL from 2014 to 2016. Early in her career, she was a Student-Athlete Tutor at the University of Illinois at Urbana-Champaign from 2012 to 2014.
Education and Expertise
Cristina is an alumna of the University of Illinois at Urbana-Champaign, where she earned a Bachelor's Degree in Chemistry. Her expertise includes managing and conducting GMP investigations, ensuring compliance with FDA, cGLP, and cGMP regulations. She has extensive skills in writing and reviewing SOPs, analytical protocols, analysis reports, and other controlled documentation. Additionally, Cristina is proficient in equipment calibrations, preventive maintenance, troubleshooting, and qualifications.
Skills and Technical Proficiencies
Cristina L. is skilled in the use of various Quality Management Systems (QMS) including Trackwise, SAP, Veeva Vault, Empower, LIMS, ELN, and SDMS. She participates in departmental efforts for equipment maintenance and calibration. Cristina has hands-on experience with a wide array of laboratory instruments such as AA, FT-IR, UV/Vis, Karl Fisher, Particle size, HPLC, and GC.