Menirva R.
About Menirva R.
Menirva R. is a Senior Quality Specialist in GMP Compliance with extensive knowledge of FDA regulations and global pharmaceutical standards. With a background in various quality and compliance roles across multiple organizations, she holds a Lean and Six Sigma Black Belt Certification and a BA in Chemistry from New Jersey City University.
Work at Insmed
Currently, Menirva R. serves as a Senior Quality Specialist in GMP Compliance at Insmed Incorporated. She has held this position since 2020, contributing to the company's commitment to quality and compliance in pharmaceutical manufacturing. Previously, she worked at Insmed as a Quality Engineer in Global Compliance from 2019 to 2020. Her role involves ensuring adherence to regulatory standards and improving quality processes within the organization.
Education and Expertise
Menirva R. holds a Bachelor of Arts in Science with a focus on Chemistry from New Jersey City University. Her educational background supports her extensive technical knowledge of FDA regulated processes, particularly the 21 CFR Parts 210 and 211 regulations. She is proficient in cGMP/GLP, USP, EP, and ICH guidelines, reflecting her strong understanding of global pharmaceutical standards.
Background
Menirva R. has a diverse professional background in the pharmaceutical industry. She began her career as a QC Chemist at West-Ward Pharmaceuticals from 2009 to 2010. She then progressed through various roles, including Scientist I and II at Ortho Clinical Diagnostics, and a Senior Technical Writer/QC Compliance position at G&W Laboratories. Her experience also includes serving as a QC Supervisor at QuVa Pharma, Inc. and a Stability Coordinator/Scientist at Ortho Clinical Diagnostics.
Achievements
Menirva R. possesses a Lean and Six Sigma Black Belt Certification, which signifies her expertise in process improvement and quality management methodologies. She has demonstrated strengths in statistical analysis, laboratory operations, and continuous improvement methodologies, such as 6S. These qualifications enhance her ability to contribute effectively to quality compliance in the pharmaceutical sector.