Provide quality oversight and advice for technology transfers between factoriesResponsible for performing quality gap assessments and risk assessmentsProvide quality oversight of the Manufacturing Science and Technology groupProvide quality oversight of the Product and Process Development groupMember of Consent Decree remediation teamMember of Project Phoenix (a redesign of deviation, CAPA, and change control management)

Directly responsible for all quality aspects of supplier and incoming qualityOversee daily operations pertaining to supplier quality operations across multiple shifts Provide information regarding operations during federal and customer audits.Conduct supplier auditsResponsible for release of all incoming materialsEnter and update status of GMP impacting materials in the QAD materials management systemEstablishment of appropriate AQLs in accordance with ANSI standardsApproval of final product inspectionsInitiation of defective material notificationsApproval of Trackwise investigations related to supplier quality issuesInteracted cross-functionally with multiple departments to ensure timely release of all incoming materials and componentsAssisted with creating an audit function in the Trackwise project tracking systemManage salaried specialists and hourly technicians Ensure training of direct reports

Directly responsible for all quality aspects of production operations on shift, including working as needed to address customer product related quality concerns or issues Responsible for providing leadership for:MQA Process Analysts Environmental Monitoring personnelQA Batch Record and Product Release groupIn-process InspectorsFinished Product InspectorsProvide technical expertise and internal technical consulting within the facility Review and approve regulated documents as needed for product disposition Conduct, review, and approve investigations as needed for atypical events Provide training on cGMPs to the QA group, Production, and PackagingProvided quality coverage directly on the production floor, in all areasConducted all New Hire Orientation on GMP/GDPResponsible for compendial review for compliance (USP, EP, JP)

Responsible for building a raw materials department, system, and staff from scratchCreated and updated SOPs and test procedures relevant to raw materials for GMP facilityResponsible for quality of all raw materials for aseptic, liquid and lyophilized parenteralsResponsible for inspection, compliance and release of all packaging materialsResponsible for vendor, supplier, contract laboratory auditsFinal document review (fill, batch, antigen, and media for EU production)Responsible for quality of water system (WFI, Pre WFI, and PSC)Chairman of Change Control CommitteeRaw material identity testing using near infrared analyzer (NIR)Total organic carbon testing (TOC)Limulus Amoebocite Lysate (LAL) testingConductivity testingHeavy metals testingNitrate testingBiological indicator testing

Managed salaried scientists and hourly techniciansDesigning and conducting research experimentsSterility TestingMycoplasma TestingBacteriostasis/fungistasis testingBacterial/fungal identificationsManaged Media fill programManaged water testing programManaged environmental monitoring programFailure reporting / investigationsGrowth support testingLAL testingContamination detection using ATP analyzerCreating, updating SOPs, QCPs, and test proceduresOrdering, receiving, shipping of hazardous materialsTraining new employees Validation of equipment

Managed salaried scientists and union workersWater system (failure reporting/investigations, trending, and corrective action)FDA ValidationsMIDI GC Bacterial identifications system proficiencyVitek bacterial identification system proficiencyBacteriostasis/fungistasis testingSanitizer effectiveness testingAntimicrobial effectiveness testingGrowth support testingSterility testingDesigning and conducting research experiments

Supervised and mentored MicrobiologistsFDA validationsVirus culture researchTissue culture researchElectrophoresis testing (western and southern blots) Mycoplasma culturing, retention, and filtrationBacterial and viral retention testingLAL assay for presence of EndotoxinExtensive work with selective filtrationContract testing for pathogens