Description
Experienced with operational excellence and continuous improvement initiatives. * Coached, lead and managed individuals and teams. * All experience in a sterile, aseptic cGMP environment. QC Laboratory: * Tested raw materials, in-process, finished products, stability samples and residual testing using HPLC, GC, UV/VIS, FTIR, TOC, conductivity, pH and wet chemistry procedures. * Trained colleagues in the above procedures * Performed/scheduled/tracked equipment installation, maintenance and calibration. * Performed OOS investigations. Perform, check and approve QC testing. * Lead laboratory investigations including OOS investigations and instrument/method troubleshooting. Followed up with root cause, retest protocol and approval of retest. * Performed special projects to support manufacturing and Quality Control/Quality Assurance investigations. * Set up/installed new instruments and equipment. Performed installation, operation and performance qualification and maintenance on new and current instruments. * Expert user of Microsoft Office, Empower, Chemstation, Documentum, PDOCS and Trackwise. * Checked and approved quality control results for raw materials, in process samples, residual samples, finished product and stability samples. Performed OOS investigations. * Headed customer complaint investigations and identification of unknown material. * Performed potency testing of Fluogen vaccine and intermediate samples by SRID assay. * Microbial Plate reading associated with environmental monitoring. Method Development: * Project leader for method development and method validation. Wrote protocols and reports for the execution of method validation and development tests using HPLC, GC, UV/VIS, FTIR and Karl Fisher. * Performed method verification and Method Transfer. * Formulated new drug products: Injectables, Lyophilized, Topical creams and Lotions. * Set up stability and accelerated testing. * Supervised teams of 2 - 6 chemists. * Transferred HPLC methods to UPLC technology. EHS/Safety: * Conducted training sessions for department procedure updates and safety initiatives. * Lead quality/safety audits for all departments. Followed up with corrective action. * Member of the HAZMAT team. HAZWOPER certified (Lapsed). * Member of the safety committee. Chaired monthly safety meetings. * Initiate/monitor safety programs and perform monthly audits. Performed/reviewed quality and safety audits and followed up with corrective actions to correct deficiencies. * Safety liaison for the department. Implemented safety initiatives and programs. * Monitored and organized the collection and disposal of hazardous waste. * Proficient with 5S and ergonomic systems. Quality Assurance: * Updated SOP's and trained colleagues ensuring compliance with written policies. * Performed quality audits. * Reviewed batch records, material specifications and procedures. Microscopy: * Proficient in use of polarizing, stereo and inverted microscopes. * Proficient in particle isolation and micro-manipulation. * Performed microscopic examination and identification of unknown samples and customer complaint testing. Published detailed reports of findings. * Prioritized, organized and tracked sample receipt and delivery of results. * Performed maintenance and calibration of microscopes. * Component inspection.
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