An energetic, quality driven individual with initiative and extensive hands-on cGMP Quality experience serving the life sciences and pharmaceutical communities in the areas of Quality Assurance, Quality Control, Pharmaceutical Manufacturing Operations, Contract Manufacturing, Validation, Stability, Raw Materials, and building/implementing Quality Systems. Management responsibilities within pharmaceutical and CMO companies include lab management, auditing (internal & external), product release, documentation review, investigations, establishing specifications, QC testing, working with biologics (cells/viruses), drug substance/drug product, implementing/executing validations, raw material control and stability.
Listed skills include Gmp, Validation, Analytical Chemistry, Fda, and 31 others.