jessica claire montgomery street san francisco ca 94105 555 4321000 resumesampleexamplecom 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 invivo 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 psiblast tree view gen bank pub med gene pix pro 50 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 042016 present transunion mt state consultant provide consulting technical training proper aseptic techniques fda regulatory compliant behavior required working aseptic andor clean environment cleanroom asepticgowning technique training iso 5 iso 8 cleanroom technique training iso 5 iso8 cleanroom asepticmanufacturing technique training iso 5 iso 8 environmental monitoring technique training aseptic cleaning technique training sterile gloves techniques training basic aseptic technique training consultant microbiologist 122016 052017 bd becton dickinson company nashville tn conduct bio burden testing media testing water clean steam testing aseptic gmp facility qualification facility qualification equipmentprocess 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 documentsprotocols 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 fillfinish manufacturing fermentation recovery purification aseptic processing nonsterile manufacturing design administer microbiological programs including environmental monitoring investigations laboratory manufacturing microbial excursions outofspecification 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 eg fda 483 warning letters regulatory dossier development support process analytical technology pat support microbiology rapid microbiological method suppliers industry endusers 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 trainerlead aseptic techniquebehavior specialist 122011 122015 hospira city state spearheaded expansion development initiatives aseptic area used roleplaying 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 oneonone tutoring sessions new employees administered performance reviews evaluate participants 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 longterm planning strategies initiatives accordance 21 cfr 820 assess external service providers andor site staff training needs support development eventual training programs terminal sterilization filling line participated research regulatory issues dissemination regulatory information production qa qc rd departments senior management required actively participated evaluation regulatory compliance documentsproductsprocess test method changes reviews labeling labels compliance regulatory requirements conducted internal audits lead department initiatives improve current processes procedures quality control assistant scientist 102010 102011 emergent city state executed experimental tasks obtained interpret experimental data conducted tmc lal microid 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 microid 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 assistanttrainer 082007 062009 michigan state university 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 eg minispec shared microscope etc laboratory supplies materials trained developed undergraduate research assistants proper protocol procedures hiv lab conducted oneonone tutoring sessions new students microbiology laboratory technician 062007 092008 sparrow hospital 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 chemistryspecific 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 scaleup processes computed taxes owed applying prescribed rates laws regulations complied good laboratory practices title 21 cfr part 11 education bs microbiology may 2009 michigan state university east lansing mi 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