summary qualifications jessica claire montgomery street san francisco ca 94105 555 4321000 resumesampleexamplecom detail oriented analytical chemist laboratory leader 15 years successful quality management experience used mentor develop staff form strengthen cross functional relationships assure audit ready operation realize cost savings dedication continuous quality improvement 15 years quality management experience bsms degrees chemistry character driven collaborative leadership practice style accomplished project manager tqm dmaic6sigma green belt trained established track record implementing positive procedural change continuous quality 10 years international product technical improvement providing exemplary support transfer experience existing operation experience consultant icon knoxville tn 2010 current 8200622008 12010current subject matter expert serving legal academia industrial professions primarily telephone online group meeting consultations providing clients scientific insights needed make informed decisions ccoisultant qa employee development project review janssen biologics jj biopharmaceuticals city state 012013 2014 project technical data summary review bla submissions protocols stability studies raw material supplier evaluations employee training mentoring practice interimcontract qc laboratory manager zoltek city state temporary manager permanent qc manager personal leave site 30 staff 2 technicians supporting 245 operation 2011 112011 included raw material evaluation approval process sample analysis finished product release customer complaints dicector quality laboratories biotest pharmaceuticals biopharmaceuticals city state responsible manufacturing rd technical transfer support 012008 2010 training coaching development staff 45 7 direct reports 24hour 5day operation groups included stability raw materials lims environmental monitoring med techs analytical methods development qc process product lot release groups assured strict laboratory regulatory compliance capa remediation establishment maintenance audit ready operating groups established past addition management reports two analytical development chemists also reported directly order maintain floor presence aid method development trouble shooting technical transfer projects monager ii quality laboratories baxter healthcare biopharmaceuticals city state 112003 052006 received six sigmadmaic green belt training laboratory cycle time reduction projects overall increased operational efficiency responsible site quality laboratories including raw materials process finished goods analysis technical services samples validation method development stability etc staff appox 45 professionals 6 direct 247 support responsible budget excess 75 mm annually hosted supported monthly audits us foreign customers 3 fda audits various international regulatory bodies asoociate director quality laboratories lonza biologics cmo biopharmaceuticals city state 052002 112003 responsible raw materials analytical methods development quality control biochemistry technical lims em laboratory programs cgmp staff 70 employees analysts supervisors managers 7 direct mgr supervisory reports one seven site directors planning implementing strategic initiatives supporting positive cultural growth portsmouth nh site supporting 460 employee mammalian cell culture manufacturing facility managed successful relocation project quality laboratories 4500 sqftto 17000 sqft including lims deployment concurrently providing seamless manufacturing support cutting needed budgeted 11mm less 8mm requiring additional head count slated 15 prior coming site reduced group operating cost 25 10 months due successful implementation continuous quality improvement initiatives left company downsizing quality control laboratory manager genzyme diagnostics medical devicebiologics city state 052001 052002 supported manufacture test kits subsequent raw materials including mab process finished product release management quality control technical services laboratory medical device manufacturer responsible group 10 professionals cgmp compliant cfr 810 qcanalytical laboratory directed customer servicecomplaint resolution stability programs proficiency studies raw material evaluations equipment instrument validations etc left due facility closure operations moved ca quality control laboratory manager dsm catalytica pharmaceuticals cmo api mfg city state 051999 052001 quality control laboratory manager supporting 247 pharmaceutical api contract production operation managed eight twelve professional chemists supervisors gmp compliant cfr 210211 qc analytical laboratory drove transfer optimization analytical methodology assisted development supported implementation site spcsqc program production product release development plant laboratory sops raw material suppler assessments cost minimization project etc reduced permanent temporary staff turnover approximately 90 time investment employee empowerment commitment investment future success left last batch manufactured catalytica processes moved nc purchase dsm sloervisor product support ge power water city state 051993 051999 research scientist supervisor corp rd product support1997 1999 senior scientist corp rd product support 19951997 scientist corp rd product support 19931995 managed corporate technical services quality control remote beaumont tx quality control laboratory us contact 3 international satellite laboratories widnes uk helsingborg sweeden qualitno italy direct reports included laboratory mgr process chemist quality control laboratory staff beaumont tx facility local qc laboratory trevose pa managed total team five local fourteen remote chemiststechnicians development site implementation analyticalqc testing methods sop harmonization well implementation technology product transfer protocols global facilities supervised corporate technical services laboratory responsible investigation disposition product quality incidents global raw materials manufactured purchased polymers globally manufactured reaction products provided quality control support corporate rd organic synthesis polymer chemists support consisted analytical qc methods development hplc gc spectroscopic etc analysis raw materials finished good samples transfer specification requirements methods production sites confirming data collectionreporting system