This person will report to the Director of QC/AD. Responsible for all facets of managing the QC department at Stemedica. Oversee Environmental Monitoring and Biology Testing Programs. Responsible for interpreting regulations and ensuring compliance to departmental policies and procedures. Manage multiple quality systems and lead QC system improvement projects. Manage and develop QC personnel. Perform high level QC data analysis and serve as technical resource for the QC department. Interface with Manufacturing, Facilities and Quality Assurance leadership and participate/lead interdepartmental teams to address quality-related issues.

Essential Duties and Responsibilities include, but are not limited to:• Oversee Microbiological testing and review of Environmental Monitoring Data, and QC test data, Sterilization Records, and QC laboratory equipment usage, calibration, and maintenance.• Ensure cGMP compliance in QC lab• Perform and /or Assist in QC-related internal and external audits.• Identify and report non-conformances/deviations/out-of-specification events.• Interact with Production, Quality Assurance, Regulatory Affairs and other Departments to provide testing data and other required quality-related information needed to support clinical studies.• Write analytical method procedures and validation protocols/reports.• Ensure the proper tracking and storage of test samples and associated controlled documentation.• Maintain documentation, certifications, and training records for QC staff.• Responsible for processing, incorporating, releasing, tracking, and training of QC-related new test procedures and SOPs and changes to the Test procedures/SOPs.• Responsible for investigating and processing Deviations, Out of Specifications, and Out of Trend, QC events.• Assist in packaging, labeling, releasing and shipping ELAD C3A cell cartridges to Clinical sites.• Assist in reviewing of executed Manufacturing Batch Production Records.• Ensure that clinical products are tested in compliance with cGMP regulations and in such a way as to ensure the identity, strength, quality and purity of the drug product.• On call 24 hours a day, 7 days a week for sending ELAD to Clinical sites.

The Quality Assurance Specialist assists in the day to day activities of the QA department for the manufacturing of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial products.

The Quality Control Manager is responsible for both managing, supervising and performing various quality activities. The position requires an understanding of Quality Assurance, Validation, and Quality Control systems. Responsibilities include creating, performing, and/or reviewing in-process testing, contract testing, and final product testing. The Quality Control manager will represent the Quality Control function of the Quality Group and will ensure manufacturing activities reflect proper aspects of Quality Control. Other duties as assigned by VP Quality Director.

The Quality Assurance Specialist works directly with the QA management assisting with various quality assurance activities including document control, engineering changes, nonconforming materials reports, corrective actions and preventative actions, variances, internal audits and other QA functions. The specialist is generally responsible for all activities within a manufacturing group at the company including review and approval of batch records, initiation and review of engineering change notices, variances and other quality systems. The specialist may participate in the audit process, assisting with internal audits, and may also assist management in performing higher-level QA functions as their expertise allows.

Performs environmental monitoring of clean rooms and water systems.Adheres to cGMP and SOP requirements.Compiles data for documentation of test procedures.Analyzes data results and presents conclusions to supervisor.Creates reports on status of facility critical systems (Environmental Monitoring Data, Water Systems, and Compressed Gas Systems)Develops new testing methods with guidance from supervisor.Trains lower level personnel on quality control methods and SOPsAssists other technical personnel on issues and problems.Completes other duties as assigned by supervisor.Troubleshoots data and testing processesLead and conduct internal audits in accordance with company quality assurance requirements.

Bacterial/Yeast Fermentation using 5L, 20L, 50L, 140L, and 750L capacity fermentors.Harvest cells using Sharple centrifuges.QC of finished product using Northern, Southern, Western Blot techniques.Update documents and SOP's as required.

Current Good Manufacturing Practice for Quality Control LaboratoryWater testing (DI, WFI, HWI, CS) systems and product by bioburden, conductivity, endotoxin, and particulateEnvironmental Monitoring of cGMP facilities under class 100, 1000, and 10,000 FDA and ISO class standardsConduct OAL investigations under current Environmental Monitoring program.Product testing for bioburden, endotoxin, sterility, and particulates in stability programAnalytical Training in UV-Vis, GEL-IEF, and TOC analysisCreate/revise Quality Control Lab Standard Operating ProceduresCreate/execute validation protocols associated with QC MicroWrite Quarterly and Annual Environmental Monitoring Reports (EM, Water, etc.)

Current Good Manufacturing Practice (cGMP)Use of Clean In Place (CIP) and Steam in Place (SIP) systems for all manufacturing vesselsPreparation of all Buffers and Solutions for use in production using 400L and 600L vesselsBacterial Fermentation in 100L and 500L fermenterCollection of Bacteria using large scale centrifuge (P12)Chemical lyses of product using 50L lysis skidFiltration of lysate through CUNO Filtration systemPlasmid DNA isolation for analysis using Southern Blot techniqueSpectrophotometer for determination of DNA concentrationQuality Control Environmental Monitoring (bioburden, TOC, Endotoxin, microscopy)

cell culture maintenance and isolation for small scale productionProtein isolation (Western Blot, supernatant filtration, knowledge of FPLC)Immunological techniques (ELISA)Immunohistochemistry for microscopyLSM5 confocal microscope for imaging of cells

Last duty assignment, served as mid-level manager at LRMC from January 2004 - February 2005. Deployed as part of Operation Iraqi Freedom.

Research on bacterial siderophores using genetically modified E. coli bacteria.