CONSULTANT Professional Summary Highly organized Microbiologist successful managing people time, expertise Molecular Genetic Research, Quality Control System Operations, Cross Functional Leadership, Consulting, Training Development Validation new products facilities. Skills RNA isolation knowledge Proficient PCR In-vivo transcription Published researcher Skilled genotyping Protein isolation Southern blotting Transcription profiling Equipment maintenance Statistical analysis ELISA assay Expert design control ISO 9001 environment Extraction Separation purification techniques Trained lab safety MS Office proficiency Training proposals Expert developing inventory systems Creative instruction styles techniques Certified Training Specialist Consulting Project management Presentations expert Charismatic public speaker Skilled working special needs adults Proficient creating maintaining schedules Taught Aseptic technique lessons 400 participants Instructional technologies knowledge Intuitive people management skills Assisted OOS Investigations Change Control Quality Systems RDP, NCBI, TIGR, KEGG, OMIM, Entrez, Minitab, PSI-Blast, Tree View, Gen Bank, Pub Med, Gene Pix Pro 5.0 analysis COGS CDD MS Office, MS Outlook, Citrix Sever, FTP clients, LIMS, SAP, Isotrain, IKAT, VIBES, COGNOS, Word, Power Point, Access, Outlook. Work History Consultant 04/2016 Current Company Name – City State As Consultant, I provide consulting technical training proper aseptic techniques FDA regulatory compliant behavior required working aseptic and/or clean environment. Clean-room (Aseptic)Gowning Technique Training (ISO 5 ISO 8)* Clean-room Technique Training (ISO 5 ISO8) Clean-room (Aseptic)Manufacturing Technique Training (ISO 5 ISO 8) Environmental Monitoring Technique Training Aseptic Cleaning Technique Training Sterile Gloves Techniques Training Basic Aseptic Technique Training. Consultant Microbiologist 12/2016 05/2017 Company Name – City State Conduct Bio Burden testing, Media Testing, water clean steam testing Aseptic GMP Facility Qualification. Facility Qualification equipment/process methods validation MODA (environmental monitoring system) development uses. Commissioning Qualification Validation (CQV) activities Lead teams validation professionals, provided subject matter expertise validation variety utility, facility process equipment. Developed project scope statements, estimates proposals. Developed policies, programs, standard operating procedures. Developed executed validation documents/protocols equipment compliance. IQ OQ documentation development execution MODA System. Provide regulatory, quality compliance solutions pharmaceutical, biotech, medical device regulated industries. Develop microbiological monitoring, control continuous improvement strategies API fill-finish manufacturing, fermentation, recovery purification, aseptic processing non-sterile manufacturing. Design administer microbiological programs including environmental monitoring, investigations laboratory manufacturing microbial excursions out-of-specification findings, laboratory audits, optimization management, laboratory facility design qualification, cGMP compliance, Pharmacopoeia compliance, barrier isolator design microbiological validation, microbiology method protocol development, validation technology transfer, contact lens care formulation development, manufacturing, stability testing product release, disinfection, sterilization use biological indicators, cleaning validation, process development, regulatory audit response (e.g., FDA 483 warning letters), regulatory dossier development support, Process Analytical Technology (PAT). Support microbiology rapid microbiological method suppliers industry end-users developing next generation technology platforms, validation testing plans, financial return investment (ROI) strategies, commercialization approaches, global regulatory pharmacopoeia compliance. Act subject matter expert microbiology technology companies due diligence, partnership, collaboration, merger acquisition activities. Expert witness matters related pharmaceutical microbiology, ophthalmic formulations, contamination control, antimicrobial preservative effectiveness, sterilization, pharmacopoeia interpretation compliance, USP microbiology test methods, laboratory manufacturing GMPs, formulation development stability, sterile nonsterile manufacturing, research development, product quality. Corporate Trainer/Lead Aseptic Technique/Behavior Specialist 12/2011 12/2015 Company Name – City State Spearheaded expansion development initiatives Aseptic Area. Used role-playing, simulations, team exercises, group discussions, videos lectures instruct participants variety ways. Assessed training needs surveys, interviews employees, focus groups consultation managers. Created online training program used video training conferences. Organized training 25 new employees per week. Increased performance scores 80% developing new employee processes. Extensively trained new existing employees. Planned delivered account management training average 10 account managers per week. Reviewed daily metrics account executives employees evaluate strengths weaknesses. Monitored participant workflow behaviors throughout training process. Conducted one-on-one tutoring sessions new employees. Administered performance reviews evaluate participant's progress. Clearly communicated objectives lessons, units, projects participants. Used variety assessment tools strategies improve instruction methods. Addressed questions training program participants. Created online training courses Aseptic Terminally Sterile Area. Assumed ownership training program initiatives. Align functional managers management training records ensure individual training plans training records accurate date accordance 21 CFE Part 11 Identified core competencies assigned functional areas develop, within Quality System, short long-term planning strategies initiatives accordance 21 CFR 820 Assess external service providers and/or site staff training needs support development eventual training programs Terminal Sterilization Filling Line. Participated research regulatory issues dissemination regulatory information Production, QA, QC, R&D departments senior management required. Actively, participated evaluation regulatory compliance documents/ products/ process/ test method changes. Reviews labeling labels compliance regulatory requirements. Conducted internal audits. Lead department initiatives improve current processes procedures. Quality Control Assistant Scientist 10/2010 10/2011 Company Name – City State Executed experimental tasks Obtained interpret experimental data Conducted TMC, LAL, Micro-ID, TOC, Purification Test Reviewed edited protocols standard operating procedures (SOPs) Maintain regular laboratory system functions group Ensure compliance cGMP, FDA, SOPs guidelines regulations. Performed tests water, environment detect harmful microorganisms obtain information sources pollution contamination. Cleaned maintained laboratory equipment. Stocked rotated prepared growth media. Performed routine monitoring cleanroom manufacturing environments Performed micro'ID organism analysis. Perform compliance adherence checks FDA, GMP regulations Collected analyzed biological data relationships organisms environment. Interpreted research findings summarized data reports. Complied Good Laboratory Practices Title 21 CFR Part 11. Collected processed specimens clinical protocols. Laboratory Manager Laboratory Technological Assistant/ Research Assistant/Trainer 08/2007 06/2009 Company Name – City State Ordered laboratory equipment supplies. Operated genetic analyzer sequence DNA. Kept accurate databases specimens collected stored repository. Collected processed specimens clinical protocols. Successfully completed transcription profiling experiments. Complied Good Laboratory Practices Title 21 Code Federal Regulations Part 11. Scheduled trained student staff members. Managed overall laboratory functions. Investigated impact intrinsic target properties siRNAs pharmaceutical properties. Extracted DNA genotype samples using SNP technology. Interpreted research findings summarized data reports. Collected analyzed biological data relationships organisms environment. Programmed computers store, process analyze data. Maintained laboratory instruments developed new laboratory equipment. Interpreted test results developed nonstandard tests. Ordered chemicals analysis prepared reagents analysis. Maintained compliance DEC EPA. Set standards sampling analysis data interpretation using effluent analysis. Operated wet methods instrumentation analysis. Accurately inventoried lab chemicals supplies. Monitored maintained specialized lab equipment (e.g. Minispec, shared microscope, etc.), laboratory supplies, materials. Trained developed undergraduate research assistants proper protocol procedures HIV lab. Conducted one-on-one tutoring sessions new students. Microbiology- Laboratory Technician 06/2007 09/2008 Company Name – City State Maintained laboratory instruments developed new laboratory equipment. Organized lab test solutions, compounds, reagents. Routinely calibrated scales minimize leakage due calibration errors. Determined equipment operating efficiency. Interpreted test results developed nonstandard tests. Maintained records Michigan Department Health audits. Ordered chemicals analysis prepared reagents analysis. Recorded test results using variety chemistry-specific software programs. Operated wet methods instrumentation analysis. Accurately inventoried lab chemicals supplies. Collaborated business units cost model analysis. Created rapid screening testing factory find acceptable materials. Steered process development experiments lab support scale-up processes. Computed taxes owed applying prescribed rates, laws regulations. Complied Good Laboratory Practices Title 21 CFR Part 11. Education B.S Microbiology May 2009 Michigan State University City State Microbiology Skills 21 CFR Part 11, account management, API, aseptic techniques, Aseptic Technique, Basic, calibration, chemistry, Citrix, cleaning validation, COGNOS, conferences, Consultant, consultation, Consulting, continuous improvement, clients, databases, DEC, Department Health, DNA, documentation, due diligence, ELISA, staff training, Equipment maintenance, senior management, experiments, Filling, financial, focus, FTP, functional, GMP, Good Laboratory Practices, design, instruction, internal audits, interpretation, inventory, IQ, ISO 5, ISO 8, ISO8, ISO 9001, laboratory equipment, lab test, regulatory compliance, letters, LIMS, people management, materials, Access, MS Office, MS Outlook, Outlook, Power Point, Word, Minitab, next, optimization, OQ, PCR, performance reviews, policies, Presentations, process development, processes, process equipment, progress, Project management, proposals, protocols, public speaker, Quality, QA, research, researcher, safety, SAP, Southern blotting, specification, Statistical analysis, surveys, taxes, technical training, TOC, training programs, Transcription, tutoring, Validation, video, View, workflow