Perform QMS audits of international vendors and distribution depots.RABSQ certified ISO 9001:2011 Lead Auditor.Manage audit team across 3 sites and 2 countries.Investigate supplier trends for improvement and root-cause analysis.

Managed Investigations Group and Raw Materials Group, as responsibilities transitioned Responsible for 15 chemists supporting FP/Stability/Process Validation testing.* Led efforts to reduce cycle time by 50%.* Implemented efficiency improvement initiatives concerning HPLC data packets, sample tracking, and specialization of testing.Led group of chemists for comprehensive overhaul of QC SOPs to bolster compliance with regulations.Initiated and conducted frequent laboratory… Show more Managed Investigations Group and Raw Materials Group, as responsibilities transitioned Responsible for 15 chemists supporting FP/Stability/Process Validation testing.* Led efforts to reduce cycle time by 50%.* Implemented efficiency improvement initiatives concerning HPLC data packets, sample tracking, and specialization of testing.Led group of chemists for comprehensive overhaul of QC SOPs to bolster compliance with regulations.Initiated and conducted frequent laboratory and technical services investigations.Re-trained all QC analysts on proper HPLC use, maintenance and troubleshooting to bolster individual abilities. Assisted in third-party audits of contract laboratories for method development and routine testing. Show less

Responsible for 5 chemists across multiple facilities in 3 states, including annual performance evaluations, for a manufacturer of OTC pharmaceuticals and vitamins.Conducted routine internal audits of Quality Control and R&D labs for cGMP adherence.Proficient in application of ICH, FDA, and CDER guidelines for development and validation.Prepared technical reports and summaries directly reportable to FDA.Recognized by FDA investigators for technical expertise.Responsible… Show more Responsible for 5 chemists across multiple facilities in 3 states, including annual performance evaluations, for a manufacturer of OTC pharmaceuticals and vitamins.Conducted routine internal audits of Quality Control and R&D labs for cGMP adherence.Proficient in application of ICH, FDA, and CDER guidelines for development and validation.Prepared technical reports and summaries directly reportable to FDA.Recognized by FDA investigators for technical expertise.Responsible for initial review of validation protocols and final review of finished reports.Managerial responsibilities also included budgeting and project management, as well as technical liaison for outside labs.Wrote validation protocols, method development reports, and validation final reports. Show less

Responsible for quality control testing, release and stability testing of sterile-injectable products.Millennium database administrator, involving data back-ups and data integrity management.Conducted and reviewed testing procedures according to USP/EP/JP monographs.

Performed all QC analytical techniques utilizing HPLC via TurboChrom software.Proficient in performing both isocratic and gradient HPLC methods.Developed a thorough understanding of USP guidelines.Experienced in both performing experiments and reviewing other individuals' documentation.Self-taught and demonstrated expertise in chromatography techniques and instrumentation.Promoted from Q/C Chemist I to Chemist II after only 3 months.